Publications by authors named "Nandini Menon"

41 Publications

Weight loss and its impact on outcome in head and cancer patients during chemo-radiation.

Oral Oncol 2021 Sep 24;122:105522. Epub 2021 Sep 24.

Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre and HBNI, Mumbai 400012, India. Electronic address:

Background: Weight loss during chemotherapy and its impact on the cancer outcomes have been invariably reported in the literature. We also did a post-hoc analysis of a randomized phase III trial to see the same.

Materials And Methods: The database of a recently published randomized study comparing cisplatin-radiation with nimotuzumab cisplatin-radiation was used for this analysis. Week-wise weight loss during the course of treatment was noted. The impact of severe weight loss (grade 2-3) on progression-free survival (PFS), locoregional control (LRC) and overall survival (OS) was studied using the Kaplan Meier method. Binary logistic regression analysis was used to see the effect of various factors.

Results: Out of a total of 536 patients, weight loss was captured in 524. Out of these 524 patients, any degree of weight loss was seen in 293 (55.91%) patients. Grade 1 weight loss was noted in 192 (36.6%) patients, grade 2 in 96 (18.3%) and grade 3 in 5 (1%) patients. The 2-year PFS was 53% and 57.1% in severe and non-severe weight loss groups respectively (p-value = 0.36). The 2-year LRC was 60% in patients with severe weight loss, while it was 63.5% in those with non-severe weight loss (p-value = 0.47). The 2-year OS was 59.3% versus 62.2% in severe and non-severe weight loss cohorts respectively (p-value = 0.21). None of the factors was found to be associated with severe weight loss.

Conclusion: Severe weight loss was uncommon in our patients. Weight loss during treatment was not associated with poor survival outcomes.
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http://dx.doi.org/10.1016/j.oraloncology.2021.105522DOI Listing
September 2021

Study of Treatment Outcome in Adults with TFE-Related RCC.

South Asian J Cancer 2021 Apr 4;10(2):92-96. Epub 2021 Sep 4.

Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, Maharashtra, India.

TFE Translocation renal cell carcinoma (TRCC) represents 1 to 5% of all cases of renal cell carcinoma, with the highest frequency among children and young adults. Management of these tumors is not very well defined in literature. Although in pediatric age group it has favorable prognosis, in adults it has an aggressive nature, with poor outcome. This is a retrospective analysis of treatment outcome in adult patient 18 years or above treated at our hospital between January 2013 and November 2018. Clinical and pathological data of 26 patients from a single institution diagnosed with TRCC between January 2013 and November 2018 were retrospectively reviewed. All cases of TRCC were confirmed with immunohistochemistry or fluorescence in situ hybridization. We analyzed our data of patients treated with surgery only or who progressed after surgery and treated with systemic therapy or who presented with upfront unresectable or metastatic disease treated with systemic therapy with respect to event-free survival (EFS) and overall survival (OS). Between January 2013 and November 2018, 26 adult patients who were treated at our center were eligible for this analysis as per our criteria. Out of 26 patients, 25 patients had radical surgery after evaluation and 1 had metastatic disease who was started on systemic therapy. Out 25 patients who were treated with radical surgery, 16 patients progressed and they were started on systemic therapy except for 1 patient who defaulted. Median time to start systemic therapy among patient treated with curative nephrectomy was 13 months. Median EFS and median OS among overall population were 22 and 30 months, respectively. Among 16 patients who were treated with systemic therapy, median EFS to first-line therapy was 8 months and to second-line therapy was 2.5 months. Median OS was 17 months in patients treated with systemic therapy. TRCC is rare in adult population but carries significant risk of disease progression even after initial curative treatment with potential response to targeted therapy for short duration.
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http://dx.doi.org/10.1055/s-0041-1731264DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8460340PMC
April 2021

Demographics, Pattern of Care, and Outcome Analysis of Malignant Melanomas - Experience From a Tertiary Cancer Centre in India.

Front Oncol 2021 8;11:710585. Epub 2021 Sep 8.

Department of Nuclear Medicine, Tata Memorial Hospital, Homibhabha National Institute, Mumbai, India.

Background: Treatment of malignant melanoma has undergone a paradigm shift with the advent of immune checkpoint inhibitors (ICI) and targeted therapies. However, access to ICI is limited in low-middle income countries (LMICs).

Patients And Methods: Histologically confirmed malignant melanoma cases registered from 2013 to 2019 were analysed for pattern of care, safety, and efficacy of systemic therapies (ST).

Results: There were 659 patients with a median age of 53 (range 44-63) years; 58.9% were males; 55.2% were mucosal melanomas. Most common primary sites were extremities (36.6%) and anorectum (31.4%). Nearly 10.8% of the metastatic cohort were BRAF mutated. Among 368 non-metastatic patients (172 prior treated, 185 de novo, and 11 unresectable), with a median follow-up of 26 months (0-83 months), median EFS and OS were 29.5 (95% CI: 22-40) and 33.3 (95% CI: 29.5-41.2) months, respectively. In the metastatic cohort, with a median follow up of 24 (0-85) months, the median EFS for BSC was 3.1 (95% CI 1.9-4.8) months versus 3.98 (95% CI 3.2-4.7) months with any ST (HR: 0.69, 95% CI: 0.52-0.92; P = 0.011). The median OS was 3.9 (95% CI 3.3-6.4) months for BSC alone versus 12.0 (95% CI 10.5-15.1) months in any ST (HR: 0.38, 95% CI: 0.28-0.50; P < 0.001). The disease control rate was 51.55%. Commonest grade 3-4 toxicity was anemia with chemotherapy (9.5%) and ICI (8.8%). In multivariate analysis, any ST received had a better prognostic impact in the metastatic cohort.

Conclusions: Large real-world data reflects the treatment patterns adopted in LMIC for melanomas and poor access to expensive, standard of care therapies. Other systemic therapies provide meaningful clinical benefit and are worth exploring especially when the standard therapies are challenging to administer.
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http://dx.doi.org/10.3389/fonc.2021.710585DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8456006PMC
September 2021

An observational study to evaluate factors predicting survival in patients of non-small cell lung cancer with poor performance status in resource-constrained settings.

Ecancermedicalscience 2021 5;15:1274. Epub 2021 Aug 5.

Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai 400012 India.

Background: A significant proportion of non-small cell lung cancer (NSCLC) patients present with poor performance status (PS) at baseline are almost always excluded from the clinical trials leading to availability of only limited data in this subgroup.

Patients And Methods: This was an observational single institutional study. The eligibility criteria for inclusion were a histologic or cytologic diagnosis of advanced NSCLC and Eastern Cooperative Oncology Group PS 3 or 4. All patients coming between June 2015 and December 2018 were evaluated for inclusion in this study.

Results: A total of 245 patients were enrolled in the study. The median age of the patients was 63 years (range 25-89), 142 (58%) were male, 196 (80%) had adenocarcinoma histology and 192 (78.4%) has PS 3 while rest (21.6%) had PS 4. Out of 245 patients, 192 (78.4%) received oral tyrosine kinase inhibitors (TKI) and supportive care, 45 (18.4%) received supportive care alone, while 8 (3.2%) patients received chemotherapy along with supportive care. Median overall survival (OS) was 3 months (95% CI: 1.8-4.2) in patients who received oral TKI versus 1 month (1.0-2.9) in patients who received supportive care alone (log-rank = 0.013). The median OS for epidermal growth factor receptor (EGFR) mutant patients who received oral TKI was 12 months (95% CI: 7.7-16.3), while it was 3 months (95% CI: 1.5-4.5) for patients who were EGFR wild-type and received TKI on compassionate basis (HR = 0.50; 95% CI: 0.32-0.77; = 0.001).

Conclusions: The use of oral TKI on a compassionate basis led to improvement in survival in the overall cohort of the patients; this was principally driven by EGFR-mutated patients.
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http://dx.doi.org/10.3332/ecancer.2021.1274DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8426023PMC
August 2021

Quality of life in patients with locally advanced head and neck cancer treated with concurrent chemoradiation with cisplatin and nimotuzumab versus cisplatin alone - Additional data from a phase 3 trial.

Oral Oncol 2021 Sep 21;122:105517. Epub 2021 Sep 21.

Department of Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India. Electronic address:

Introduction: The addition of Nimotuzumab to radical chemoradiation (CRT) improved outcomes in patients with locally advanced head and neck squamous cell carcinoma (LAHNSCC) undergoing radical CRT in a phase 3 randomized trial. The current study focuses on the quality of life (QoL) of patients in this trial.

Methods: In this phase III randomized trial, patients with newly diagnosed, nonmetastatic, stage III/IV LAHNSCC of the oral cavity, oropharynx, hypopharynx, or larynx were randomized to receive cisplatin 30 mg/m or cisplatin 30 mg/m with nimotuzumab once a week with curative radiotherapy. The primary end point of the trial was PFS. The aim of the current study was to compare the QoL between the two arms. QoL was assessed using the EORTC QLQ-C30 (v3.0) and HN-35 (v1.0). The linear mixed-effects model was used for longitudinal analysis of QoL.

Results: 536 patients were randomized in this trial (268 in each arm) and 423 patients were included for QoL analysis. There was a significant change in the global health status QoL scores over time (p = 0.0016) with no difference between the two arms (p = 0.396). On longitudinal analysis there was a significant difference in the QoL scores in most of the function & symptom scales over time, but there was no significant difference in these scores between the two arms. QoL scores for most symptom scales worsened during treatment and improved thereafter in both arms.

Conclusion: The addition of nimotuzumab to cisplatin based chemoradiation in LAHNSCC improved PFS, LRC and DFS without negatively impacting QoL.
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http://dx.doi.org/10.1016/j.oraloncology.2021.105517DOI Listing
September 2021

Aspiration pneumonia in head and neck cancer patients undergoing concurrent chemoradiation from India: Findings from a post hoc analysis of a phase 3 study.

Cancer Med 2021 Oct 8;10(19):6725-6735. Epub 2021 Sep 8.

Department of Medical Oncology, Tata Memorial Centre, HBNI, Mumbai, India.

Background: There are limited data from low- to middle-income countries (LMIC) on the incidence, risk factors, treatment outcomes, and antibiotic susceptibility spectrum of aspiration pneumonia (AsP).

Methods: We conducted a post hoc analysis of a randomized control trial in which adult patients with locally advanced head and neck cancers had received 66-70 Gy of radiation combined with cisplatin 30 mg/m weekly for 6-7 weeks or cisplatin at the same dose with nimotuzumab 200 mg once weekly till the completion of radiation. The following data were extracted and analyzed-the incidence of AsP, time to the onset of AsP, risk factors, treatment outcomes of AsP, and its impact on progression-free survival (PFS), locoregional control (LRC) rates, and overall survival (OS).

Results: Out of 536 patients enrolled in the study, 151 (28.3%, 95% confidence interval [CI] 24.5-2.1) patients developed AsP. The median time to develop AsP was 39 days (95% CI 34-44). Only baseline dysphagia (odds ratio = 3.76, 95% CI 1.05-13.51, p = 0.042) was associated with a significant risk of development of AsP. Among the patients in which pathogenic organism was isolated (69 patients), gram-negative species was isolated in 63 patients (89%). Cisplatin at 200 mg/m or more was delivered in 312 (81%) patients in the non-AsP cohort versus 107 (70.9%) patients in AsP cohort (p = 0.014). There was no statistical difference in LRC (hazard ratio [HR] = 1.057; 95% CI 0.771-1.448), PFS (HR = 1.176; 95% CI 0.89-1.553), and OS (HR = 1.233; 95% CI 0.939-1.618) between the two cohorts.

Conclusion: Aspiration pneumonia is a common complication in head and neck malignancies and patients with baseline dysphagia are at high risk. Gram-negative bacteria are the predominant causative agents. The use of broad-spectrum antibiotics results in resolution of symptoms.
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http://dx.doi.org/10.1002/cam4.4210DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8495270PMC
October 2021

Advances in pharmacotherapy for head and neck cancer.

Expert Opin Pharmacother 2021 Oct 30;22(15):2007-2018. Epub 2021 Jun 30.

Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.

Head and neck squamous cell carcinoma (HNSCC) is one of the most common cancers worldwide and is a leading cause for cancer-related mortality. This review attempts to give a comprehensive summary of the recent developments in pharmacotherapeutic options for locally advanced/metastatic HNSCC. In this review, the authors conducted a systematic literature search for published articles on HNSCC in the PubMed database using the keywords 'head and neck squamous cell carcinoma or HNSCC,' 'targeted therapy,' 'immunotherapy.' The search was restricted to meta-analyses, clinical trials, practice guidelines, and abstract presentations at international meetings. The final search encompassed articles published from 2010 to 2021. Articles published in languages other than English were excluded. Immune checkpoint inhibition has been the most significant advance in the treatment of R/M HNSCC. Oral metronomic therapy has emerged as an important therapeutic option for low to middle-income countries. H-RAS inhibition is one of the most promising areas of research.
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http://dx.doi.org/10.1080/14656566.2021.1948011DOI Listing
October 2021

A Survey of Satisfaction with Treatment among Brain Tumor Patients.

South Asian J Cancer 2020 Oct 12;9(4):262. Epub 2021 Jun 12.

Department of Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, Maharashtra, India.

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http://dx.doi.org/10.1055/s-0041-1729494DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8197651PMC
October 2020

Post hoc analysis of a randomized controlled trial comparing concurrent chemoradiation with cisplatin versus nimotuzumab-cisplatin, focusing on acute oral mucositis.

J Egypt Natl Canc Inst 2021 May 22;33(1):12. Epub 2021 May 22.

Department of Medical Oncology, Tata Memorial Hospital, Mumbai, 400012, India.

Background: Acute oral mucositis has been infrequently studied in the patients with head and neck squamous cell carcinoma (HNSCC) receiving once-weekly cisplatin-based chemoradiotherapy (CRT). Hence, this analysis was conducted to explore the various aspects of the same.

Results: The overall incidence of mucositis was 96.9% (n = 508) and of grade 3-5 mucositis was 61.3% (n = 321). The overall incidence of oral mucositis was similar in both the arms (CCRT and NCRT) (p value = 0.58) while grade 3-5 mucositis was more common in the NCRT arm (p value = 0.01). Out of all factors listed, the presence of nimotuzumab was the only significant risk factor for the development of grade 3 or more oral mucositis (p value = 0.01); (OR = 1.64, 95%CI 1.15-2.32). Delays in the treatment delivery were similar in both the arms.

Conclusion: Acute oral mucositis is a common occurrence in locally advanced-HNSCC patients receiving chemoradiotherapy. Nimotuzumab is a significant factor for development of grade 3 and above oral mucositis.
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http://dx.doi.org/10.1186/s43046-021-00069-1DOI Listing
May 2021

Adolescent-adult nonmetastatic Ewing sarcoma-Experience from a large developing country.

Pediatr Blood Cancer 2021 Sep 15;68(9):e29081. Epub 2021 May 15.

Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, Maharashtra, India.

Background: Outcome and toxicity data in adolescent-adult Ewing sarcoma (AA-ES) patients are sparse and merits exploration.

Methods: Histopathologically confirmed, nonmetastatic AA-ES patients, who received standard institutional combination chemotherapy regimen (Ewing's family of tumors-2001 [EFT-2001]) comprising of ifosfamide plus etoposide and vincristine, doxorubicin plus cyclophosphamide, lasting a total of 12 months between 2013 and 2018, were analyzed for treatment-related toxicities, event-free survival (EFS), and overall survival (OS).

Results: There were 235 patients (primary safety cohort [PSC]) with median age of 23 (15-61) years; 159 (67.7%) were males, 155 (65.9%) had skeletal primary and 114 (48.5%) had extremity tumors. One hundred ninety-six (83.4%) were treatment naïve (primary efficacy cohort [PEC]) and of these 119 (60.7%) had surgery. In PEC, at a median follow-up of 36.4 (interquartile range [IQR] 20-55) months, estimated 3-year EFS and OS were 67.3% (95% CI 60.3-75.1%) and 91.1% (95% CI 86.7-95.7%), respectively. Of these, 158 (80.6%) complying with intended treatment, at a median follow-up of 39 (IQR 26-57) months had an estimated 3-year EFS of 68.2% (95% CI 60.3-76.1%). In multivariable analysis, good prognostic factors included longer symptom(s) duration (HR 0.93, 95% CI 0.86-0.994), ≥99% necrosis (HR 0.30, 95% CI 0.11-0.77), and treatment completion (HR 0.32, 95% CI 0.14-0.74). Among PSC, grade 3-4 toxicities were febrile neutropenia (119, 50.6%), anemia (130, 55.3%), peripheral neuropathy (37, 15.7%), with three (1.3%) chemo-toxic deaths.

Conclusions: The outcomes of AA nonmetastatic ES patients treated with EFT-2001 regimen were comparable to those reported by others, with acceptable toxicity. This regimen can be considered a standard of care in AA-ES.
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http://dx.doi.org/10.1002/pbc.29081DOI Listing
September 2021

Molecular characterization of lung squamous cell carcinoma tumors reveals therapeutically relevant alterations.

Oncotarget 2021 Mar 16;12(6):578-588. Epub 2021 Mar 16.

Integrated Cancer Genomics Laboratory, Advanced Centre for Treatment Research Education in Cancer (ACTREC), Tata Memorial Centre, Navi Mumbai, Maharashtra 410210, India.

Introduction: Unlike lung adenocarcinoma patients, there is no FDA-approved targeted-therapy likely to benefit lung squamous cell carcinoma patients.

Materials And Methods: We performed survival analyses of lung squamous cell carcinoma patients harboring therapeutically relevant alterations identified by whole exome sequencing and mass spectrometry-based validation across 430 lung squamous tumors.

Results: We report a mean of 11.6 mutations/Mb with a characteristic smoking signature along with mutations in and among lung squamous cell carcinoma patients of Indian descent. In addition, therapeutically relevant mutations occur in 5.8% patients, significantly higher than as reported among Caucasians. In overall, our data suggests 13.5% lung squamous patients harboring druggable mutations have lower median overall survival, and 19% patients with a mutation in at least one gene, known to be associated with cancer, result in significantly shorter median overall survival compared to those without mutations.

Conclusions: We present the first comprehensive landscape of genetic alterations underlying Indian lung squamous cell carcinoma patients and identify and as potentially important therapeutic and prognostic target.
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http://dx.doi.org/10.18632/oncotarget.27905DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7984830PMC
March 2021

Immune checkpoint inhibitors in patients with solid tumors and poor performance status: A prospective data from the real-world settings.

Medicine (Baltimore) 2021 Apr;100(13):e25115

Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.

Abstract: Immune checkpoint inhibitors (ICIs) are rapidly being incorporated as treatment option either alone or in combination with chemotherapy in most of the solid tumors. Since there is very limited data of ICI in patients with poor performance status (PS) from the real world settings, we performed a retrospective audit of patients who received ICI and report the analysis based on ECOG PS of these patients.This study is a retrospective audit of a prospectively collected database of patients receiving ICIs for advanced solid tumors in any line between August 2015 and November 2018 at Tata Memorial Hospital, Mumbai, India. All statistical calculations were performed using SPSS statistical software for windows version 20.0.A total of 155 patients who received ICIs during the specified period were evaluated for this study. Baseline ECOG PS 0-1 (n = 103, 66.4%) patients was associated with median OS 9.1 (95% CI [confidence interval], 4.4-NR) months when compared to ECOG 2-4 (n = 52, 33.5%) which had a median OS of 2.9 (95% CI; 1.8-5.5) months (HR, 1.7, 95% CI, 1.1-2.7, log rank P = .017). The disease control rate for the poor PS group was 34.6%. However, 27.3% patients (95% CI: 20.3-34.3) were still alive at 1 year. Median OS in patients with PS 2 was 3.7 months (95% CI: 0-11.6) as compared to 1.8 months (95% CI: 0.2-3.4) for those with PS 3-4 (HR-2.0; 95% CI: 1.0-3.9, P = .041). The tolerance to ICIs was good with no grade 3/4 toxicities in 44 (84.6%) patients.Immune checkpoint inhibitors are a safe and effective therapeutic option even in solid tumor patients with poor performance status.
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http://dx.doi.org/10.1097/MD.0000000000025115DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8021372PMC
April 2021

Intensity-modulated radiation therapy for nasal cavity and paranasal sinus tumors: Experience from a single institute.

Head Neck 2021 07 9;43(7):2045-2057. Epub 2021 Mar 9.

Department of Pathology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India.

Background: To assess the efficacy of intensity-modulated radiation therapy (IMRT) for tumors of the nasal cavity and paranasal sinus (PNS) region.

Materials And Methods: Two hundred fourteen patients with tumors of the nasal cavity and PNS region treated with curative intent IMRT between 2007 and 2019 were included in this retrospective analysis.

Results: Fifty-one (24.1%) received definitive RT/CTRT and 163 (75.9%) received adjuvant RT. Most common histology was squamous cell carcinoma (26.1%) followed by adenoid cystic carcinoma (21.5%). The median follow-up was 43.5 months. The 5-year local control (LC), event-free survival (EFS), and overall survival (OS) for the entire cohort was 66.9%, 59%, and 73.9%, respectively. On univariate analysis treatment with nonsurgical modality, T classification and undifferentiated/poorly differentiated histology were associated with inferior 5-year LC, EFS, and OS. Four patients had late Grade 3/Grade 4 ocular toxicity.

Conclusions: IMRT should be the standard of care for tumors of PNS region across all histologies and treatment setting.
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http://dx.doi.org/10.1002/hed.26669DOI Listing
July 2021

Safety and efficacy of bevacizumab biosimilar in recurrent/ progressive glioblastoma.

Ecancermedicalscience 2021 13;15:1166. Epub 2021 Jan 13.

Department of Medical Oncology, Tata Memorial Hospital, Parel 400012 Mumbai, India.

Background: Multiple low-cost biosimilars of bevacizumab are now available but their clinical efficacy has never been compared against the original (innovator) molecule in glioblastoma. The aim of the current analysis is to compare the overall survival (OS) in recurrent/progressive glioblastoma patients between the biosimilar and innovator molecules.

Materials And Methods: Adult recurrent/progressive glioblastoma patients treated with bevacizumab from 1 July 2015 to 30 July 2019 were identified. These patients were either offered Bevacizumab innovator (Avastin, Roche) or biosimilar (BevaciRel: Reliance Life sciences or Bryxta: Zydus Oncosciences) depending upon the financial status and affordability of the patients. The primary endpoint of the study was OS, while progression-free survival (PFS) and adverse events were the secondary endpoints.

Results: There were 82 patients, out of which 57 received innovator and 25 received biosimilar bevacizumab. At median follow-up of 26 months, the median PFS was 3.66 (95% confidence interval (CI) 2.08 to 5.25) and 3.3 months (95% CI 2.38 to 4.21) in innovator and biosimilar group, respectively (Log-rank test -value = 0.072). The hazard ratio (HR) for progression was 0.61 (95% CI 0.35 to 1.05; -value = 0.075). At the time of data cut-off, the median OS was 5.53 (95% CI, 5.07 to 5.99) versus 7.33 months (95% CI, 5.63 to 9.03) in innovator and biosimilar group, respectively (Log-rank test -value = 0.51). The HR for death was 1.21 (95% CI, 0.67 to 2.17; -value = 0.51). The adverse events and safety profiles were comparable between the two groups.

Conclusion: In the recurrent/progressive glioblastoma patients, both innovator and biosimilar bevacizumab seem to have similar safety and clinical efficacy.
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http://dx.doi.org/10.3332/ecancer.2021.1166DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7929766PMC
January 2021

Effect of Early Palliative Care on Quality of Life of Advanced Head and Neck Cancer Patients: A Phase III Trial.

J Natl Cancer Inst 2021 Sep;113(9):1228-1237

Department of Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.

Background: Early palliative care (EPC) is an important aspect of cancer management but, to our knowledge, has never been evaluated in patients with head and neck cancer. Hence, we performed this study to determine whether the addition of EPC to standard therapy leads to an improvement in the quality of life (QOL), decrease in symptom burden, and improvement in overall survival.

Methods: Adult patients with squamous cell carcinoma of the head and neck region planned for palliative systemic therapy were allocated 1:1 to either standard systemic therapy without or with comprehensive EPC service referral. Patients were administered the revised Edmonton Symptom Assessment Scale and the Functional Assessment of Cancer Therapy for head and neck cancer (FACT-H&N) questionnaire at baseline and every 1 month thereafter for 3 months. The primary endpoint was a change in the QOL measured at 3 months after random assignment. All statistical tests were 2-sided.

Results: Ninety patients were randomly assigned to each arm. There was no statistical difference in the change in the FACT-H&N total score (P = .94), FACT-H&N Trial Outcome Index (P = .95), FACT-general total (P = .84), and Edmonton Symptom Assessment Scale scores at 3 months between the 2 arms. The median overall survival was similar between the 2 arms (hazard ratio for death = 1.01, 95% confidence interval = 0.74 to 1.35). There were 5 in-hospital deaths in both arms (5.6% for both, P = .99).

Conclusions: In this phase III study, the integration of EPC in head and neck cancer patients did not lead to an improvement in the QOL or survival.
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http://dx.doi.org/10.1093/jnci/djab020DOI Listing
September 2021

A real-world data of Immune checkpoint inhibitors in solid tumors from India.

Cancer Med 2021 03 16;10(5):1525-1534. Epub 2021 Feb 16.

Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.

Background: Checkpoint inhibitors (Nivolumab and Pembrolizumab) are approved for multiple indications in solid tumors. However access to these therapies is limited in low and middle income countries. Hence we performed an audit to identify accessibility, adverse event rates, compliance, progression free survival and overall survival in solid tumors.

Methods: This was a single center retrospective analysis of prospective data base of patients with non-melanoma solid tumors who were treated with immunotherapy from August 2015 to November 2018. Adverse events during immunotherapy were documented and graded using CTCAE (Common terminology criteria for adverse events), v. 4.02. The response rates to immunotherapy, toxicities and the time to onset and resolution of toxicities were also evaluated as secondary endpoints.

Results: Out of 9610 patients, only 155 patients (1.61%) could receive immunotherapy. The most common malignancies included metastatic non-small cell lung cancer, metastatic renal cell carcinoma, metastatic urothelial carcinoma and relapsed/recurrent head and neck squamous cell carcinoma. Median overall survival in patients who received immunotherapy in non-melanoma solid malignancies was 5.37 months (95% CI, 3.73-9.73). Poor performance status at baseline was the only adverse prognostic factor. The median progression free survival was 2.57 months (95% CI, 1.73-3.83). Immunotherapy was well tolerated with most common side effects being fatigue 14.8% and anorexia 5.8%. The cumulative incidence of immune related adverse events like hepatitis, pneumonitis, colitis and nephritis was less than 10%.

Conclusion: Real-world data in Indian setting confirms the benefit of immunotherapy in patients with advanced non-melanoma solid tumors.
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http://dx.doi.org/10.1002/cam4.3617DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7940210PMC
March 2021

Do palliative embolization in unresectable, unsalvageable recurrent and metastatic head and neck cancer patients help?

Eur Arch Otorhinolaryngol 2021 Sep 3;278(9):3401-3407. Epub 2021 Jan 3.

Department of Head and Neck Surgical Oncology, Tata Memorial Centre, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, Maharashtra, 400012, India.

Background: Bleeding from the unsalvageable recurrent and metastatic head and neck cancer is not an uncommon occurrence. It is extremely distressing for the patients and their family members and also to the treating doctors. One of the ways to manage this crisis is by selective embolization of the bleeding vessel.

Methodology: In this retrospective study, we audited the patients with unresectable, unsalvageable recurrent and/or metastatic head and neck cancer who underwent selective (palliative) embolization for bleeding at our institute between Jan 2015 and Nov 2019, and assessed its possible benefit in terms of bleeding free interval achieved.

Results: Twenty-six palliative embolization was done during the above mentioned period. The majority were male patients (n = 23, 88.4%) with a median age of 54.5 years. The performance status (PS) of most patients was 2 (n = 15, 57.6%). The most common bleeding vessel was the external carotid artery or one of its branches, most commonly lingual artery (n = 5). The bleeding vessel was identified and embolized with PVA/gel foam/coil/glue. All the procedures were uneventful. Out of 26 patients, 3 patients had another bleeding episode subsequently. Most patients had 20 days to 21 months of bleeding free interval. The cost involved in the procedure was between 400 and 2100 US dollars.

Conclusions: Selective embolization is an option to be considered in certain patients with unresectable, unsalvageable recurrent and/or metastatic head and neck cancer, when they present with sudden and massive bleeding to the emergency department, at centres where the facility and expertise for this procedure might be available.
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http://dx.doi.org/10.1007/s00405-020-06505-7DOI Listing
September 2021

Oral metronomic therapy in head and neck cancer - Authors' reply.

Lancet Glob Health 2021 01;9(1):e21

Department of Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai 400012, India. Electronic address:

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http://dx.doi.org/10.1016/S2214-109X(20)30471-XDOI Listing
January 2021

Review of Medicinal Use of Derivatives and the Societal Impact of Legalization.

Indian J Palliat Care 2020 Jul-Sep;26(3):369-380. Epub 2020 Aug 29.

Department of Head and Neck Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India.

Background: In recent past, there has been a rush to legalize marijuana along with a lot of support for its medicinal uses. This review intends to discuss the medicinal uses of marijuana and its adverse effects based on the current available evidence. Furthermore, it discusses the impact of legalization of marijuana.

Methodology: This was a narrative review for which a thorough literature search was conducted on the Medline and PubMed databases. A detailed search of the Internet to find relevant information on webpages was also performed.

Results: High-quality evidence for the majority of medical indications of marijuana remains investigational. Most of the available literature compares it against placebos. Postlegalization usage of marijuana has increased.

Conclusion: It would be prudent to wait for studies which prove beyond doubt the advantages of marijuana over the existing drugs and also outweigh its side effects and addiction potential. Moreover, further legalization of marijuana should only be considered after evaluating its effects at places where it is already legally available.
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http://dx.doi.org/10.4103/IJPC.IJPC_19_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7725166PMC
August 2020

Multidisciplinary brain metastasis clinic: is it effective and worthwhile?

Ecancermedicalscience 2020 5;14:1136. Epub 2020 Nov 5.

Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai 400012, India.

Background: Management of brain metastasis is a complex multidisciplinary venture. Hence, we started a multidisciplinary brain metastasis clinic for the opinion on difficult brain metastasis cases. This is the review of the impact of this clinic on the treatment decisions.

Methods: The brain metastasis clinic (BMC) was started in April 2018 and meets once a week. Data of patients discussed between 27th April 2018 and 28th June 2019 were included for this analysis. Treatment decision made by clinicians (before sending the patient to the BMC) was compared with the decisions made in BMC. The decisions were broken on a predefined proforma as the intent of treatment (curative or palliative), modalities planned (surgery, radiation, chemotherapy) and type of therapy planned (details of each therapy) in each modality were collected both pre and post BMCs. In addition, compliance of the respective physicians to BMC decision was also calculated. SPSS version 20 was used for analysis. Descriptive statistics were performed.

Results: Ninety-nine patients were discussed in this time period. The median age was 51 (range 17-68) years. The gender distribution was 70 males (70.7%) and 29 females (29.3%). Lung was the predominant site of malignancy (79, 79.8%). Thirty-one patients (31.3%) had EGFR TKI domain activating mutation, while 17 (17.2%) had anaplastic lymphoma kinase (ALK) rearrangement. The treatment plan was changed in 46 patients (46.5%). The intent of treatment was changed from palliative to curative in 5%. Change in the treatment plan with respect to surgery in 9.1%, radiation in 37.4%, chemotherapy in15.2%, targeted therapy in 22.9% and intrathecal in 6.1% patients, respectively. The compliance with the BMC decision in patients in whom it was changed was 84.8% (39, = 46).

Conclusion: Multidisciplinary management of difficult brain metastasis cases in specialised clinics has a significant impact on treatment decisions.
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http://dx.doi.org/10.3332/ecancer.2020.1136DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7685765PMC
November 2020

Systemic therapy for limited stage small cell lung carcinoma.

J Thorac Dis 2020 Oct;12(10):6275-6290

Department of Medical Oncology, Tata Memorial Hospital, Parel, Mumbai; Homi Bhabha National Institute, Mumbai, India.

Systemic treatment in small cell lung carcinoma has been a challenge for oncologists for decades. The high propensity for recurrence is usually due to distant metastasis, which makes systemic treatment an essential component of treatment in small cell lung carcinoma. The regimen of cisplatin and etoposide (established in the mid-1980's) concurrently with thoracic radiotherapy followed by prophylactic cranial irradiation (PCI) remains the standard of care in limited stage disease. Despite numerous trials, this regimen has not been improved upon. The standard combination regimen of cisplatin and etoposide has been compared to alternative platinum-containing regimens with drugs like epirubicin, irinotecan, paclitaxel, topotecan, pemetrexed, amrubicin and belotecan. Non-platinum containing regimens like ifosfamide and etoposide have also been tested. Attempts to intensify therapy have included the addition of a third drug like paclitaxel, ifosfamide, tirapazamine, tamoxifen, and thalidomide. Maintenance therapy following induction with chemotherapy, vandetanib and interferon-alpha have also been attempted. Molecularly directed targeted therapies and immunotherapeutic agents are areas of active research. In this review, we discuss the various systemic therapy options in limited stage small cell lung carcinoma, from the historical regimens to the modern-day therapy and promising areas of research. We also discuss the role of growth factors, the optimal number of chemotherapy cycles, the use of prognostic and predictive factors, the optimal timing of chemotherapy and the treatment of special populations of patients including older patients, and patients with comorbidities.
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http://dx.doi.org/10.21037/jtd-2019-sclc-11DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7656383PMC
October 2020

Results of pretreatment swallowing evaluation in patients with stage III/IV laryngeal and hypopharyngeal carcinoma.

Eur Arch Otorhinolaryngol 2021 Aug 9;278(8):3011-3018. Epub 2020 Nov 9.

Department of Head & Neck Surgical Oncology, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, Maharashtra, 400012, India.

Introduction: Laryngeal and hypopharyngeal carcinoma are among the common head and neck cancers causing considerable swallowing dysfunction. The functional status of the organ (larynx) is an important point of contention while considering the patients for organ preservation protocol.

Methodology: The aim of this retrospective study was to assess the swallowing status in stage III/IV laryngeal and hypopharyngeal carcinoma and its influence on treatment decision. We evaluated all treatment naïve patients who were referred to the swallowing clinic in 2017 (Jan-Dec) for assessment of swallowing prior to treatment initiation.

Results: One hundred patients satisfied the eligibility criteria and were included in the study. The site and stage of laryngeal and hypopharyngeal cancer cases were almost equal in number. Their median age was 58 years. Fiberoptic endoscopic evaluation of swallowing (FEES) was done in all patients. 30% of the patients only had swallowing difficulties. Only advanced T-stage (p = 0.04) had an influence on the pretreatment swallowing status. Thirty-seven patients required nasogastric tube (NGT) for feeding. By 2 month post-treatment completion, most patients on NGT could resume oral feeding.

Conclusions: Pretreatment swallowing assessment alone did not significantly seem to influence our decisions for organ preservation treatment. However, patients with aspiration could be identified and managed appropriately. Most patients on NGT could resume oral feeds post-treatment completion.
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http://dx.doi.org/10.1007/s00405-020-06460-3DOI Listing
August 2021

Lymphopenia during chemoradiation-foe or friend.

Ecancermedicalscience 2020 24;14:1109. Epub 2020 Sep 24.

Department of Medical Oncology, Tata Memorial Hospital, Mumbai 400012, India.

Background: Severe lymphopenia during treatment is considered to be a poor prognostic factor. The current literature lacks information regarding its impact on various outcomes in locally advanced head-and-neck cancer patients in a prospective setting.

Methods: We recently published a randomised study comparing cisplatin-radiation with nimotuzumab cisplatin-radiation. The database of this study was used for the present analysis. The impact of severe lymphopenia (grade 4 lymphopenia) on progression-free survival (PFS), locoregional control (LRC) and overall survival (OS) was studied using the Kaplan-Meier method and Cox regression analysis. The binary logistic regression analysis was used to see the effect of various factors on the development of severe lymphopenia.

Results: We had a total of 536 patients, of which 521 patients (97.7%) developed lymphopenia. Grade 1 lymphopenia was noted in 10 (1.9%) patients, grade 2 in 100 (18.8%), grade 3 in 338 (63.1%) and grade 4 in 73 (13.7%) patients. The median PFS was 20.53 and 60.33 months in severe and non-severe lymphopenia, respectively (hazard ratio, 0.797; -value = 0.208). The median duration of LRC was 56.3 months in severe lymphopenia, whereas it was not reached in non-severe lymphopenia (hazard ratio, 0.81; -value = 0.337). The median OS was 28.46 versus 47.13 months in severe and non-severe lymphopenia, respectively (hazard ratio, 0.76; -value = 0.11). Of various risk factors, gender was significantly associated with severe lymphopenia.

Conclusion: The occurrence of severe lymphopenia was not significantly associated with the outcomes. Gender is the only risk factor significantly linked to severe lymphopenia.
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http://dx.doi.org/10.3332/ecancer.2020.1109DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7581337PMC
September 2020

COVID-19 in cancer patients on active systemic therapy - Outcomes from LMIC scenario with an emphasis on need for active treatment.

Cancer Med 2020 12 31;9(23):8747-8753. Epub 2020 Oct 31.

Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.

Background: There is limited data on outcomes in cancer patients with coronavirus disease 2019 (COVID-19) from lower middle-income countries (LMICs).

Patients And Methods: This was an observational study, conducted between 12 April and 10 June 2020 at Tata Memorial centre, Mumbai, in cancer patients undergoing systemic therapy with laboratory confirmed COVID-19. The objectives were to evaluate cumulative 30-day all-cause mortality, COVID-19 attributable mortality, factors predicting mortality, and time to viral negativity after initial diagnosis.

Results: Of the 24 660 footfalls and 7043 patients evaluated, 230 patients on active systemic therapy with a median age of 42 (1-75) years were included. COVID-19 infection severity, as per WHO criteria, was mild, moderate, and severe in 195 (85%), 11 (5%), and 24 (11%) patients, respectively. Twenty-three patients (10%) expired during follow-up, with COVID-19 attributable mortality seen in 15 patients (6.5%). There were no mortalities in the pediatric cohort of 31 (14%) patients. Advanced stage cancer being treated with palliative intent vs others [30-day mortality 24%% vs 5%, odds ratio (OR) 5.6, 95% CI 2.28-13.78, P < .001], uncontrolled cancer status vs controlled cancer (30-day mortality37.5%% vs 4%%, OR 14, 95% CI 4.46-44.16, P < .001) and severe COVID-19 vs mild COVID-19 (30-day mortality 71% vs 3%, OR 92.29, 95% CI 26.43-322.21, P < .001) were significantly associated with mortality. The median time to SARS-CoV-2 RT-PCR negativity was 17 days [interquartile range (IQR)17-28) in the cohort.

Conclusions: The mortality rates in cancer patients with COVID-19 who are receiving systemic anti-cancer therapy in LMICSs are marginally higher than that reported in unselected COVID-19 cohorts with prolonged time to viral negativity in a substantial number of patients. The pediatric cancer patients tended to have favorable outcomes.
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http://dx.doi.org/10.1002/cam4.3423DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7724305PMC
December 2020

Factors Predisposing to the Unplanned Hospital Readmission (UHR) in Patients Undergoing Surgery for Oral Cavity Squamous Cell Carcinoma (OSCC): Experience from a Tertiary Cancer Centre.

Indian J Surg Oncol 2020 Sep 15;11(3):475-481. Epub 2020 Jun 15.

Department of Head & Neck Surgical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, Maharashtra 400012 India.

Unplanned hospital readmissions (UHR) are known to add to patient morbidity, increase the cost of the treatment, and negatively impact the postoperative quality of life. The objective of the study was to identify the UHR rates of oral cavity squamous cell carcinoma (OSCC) patients following surgery and identify the predisposing factors for UHR. We conducted this retrospective analysis of all patients who underwent surgery for OSCC in our (single) surgical unit from January 2016 to December 2018. A total of 804 patients satisfied the eligibility criteria. Majority of the patients were males ( = 650, 80.8%). The median age of the patients was 50 years (Range: 16-89 years). The most common oral cavity subsite was buccal mucosa gingivobuccal (BM-GBS) OSCC. Forty patients (5%) required an UHR after discharge. The most common reason for readmissions was flap-related issues (11/40) and orocutaneous fistula (10/40). Other causes included wound infection (7/40), chest infection (2/40), hematoma/bleeding (3/40), and other lesser prevalent causes (7/40). Factors that significantly predisposed patients for UHR were re-exploration following the initial surgery [ < 0.001, OR 7.9 (4.09-15.59)] and BM-GBS subsite [< 0.001, OR: 2.89(1.24-6.73)]. The UHR rate in our study was 5%. Patients requiring re-exploration following the initial surgery and those with BM-GBS cancer were most likely to have the UHR.
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http://dx.doi.org/10.1007/s13193-020-01135-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7501318PMC
September 2020

The role of chemotherapy in patients with small cell lung cancer and poor performance status.

Acta Oncol 2020 Dec 12;59(12):1520-1527. Epub 2020 Sep 12.

Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Center, Mumbai, India.

Background: There are limited data on the role of chemotherapy in patients with small cell lung cancer (SCLC) and poor performance status (PS).

Methods: This was a retrospective analysis of a prospective observational study in patients with SCLC and PS 3 or 4. We recorded the initial therapy, symptom improvement, response rate, overall survival (OS), and the impact of various factors on OS.

Results: From June 2010 to August 2019, we enrolled 234 patients; 185 (79%) with PS 3 and 49 (21%) PS 4. Initial therapy was best supportive care (BSC) in 49 patients (21%), standard full dose chemotherapy in 31 (13%), and attenuated chemotherapy in 154 (66%). In 89% patients treated with attenuated chemotherapy, symptom-relief occurred at a median of 3 days (IQR, 1-7). Grade 3 and higher toxicities developed in 60% patients treated with initial attenuated chemotherapy, commonly hyponatremia in 39%, neutropenia in 16%, anemia in 11%, and infection in 10%. Grade 3 and higher toxicities as a result of standard chemotherapy occurred in 89% patients treated with upfront standard full dose chemotherapy compared to 69% of patients who received initial attenuated chemotherapy with subsequent treatment escalation. Overall, there were 6 (2.6%) toxic deaths. The response rate to chemotherapy was 77%. The median OS of the patients who received any chemotherapy was significantly longer at 6 months (95% CI, 4.8-7.2) compared to 1 month (95% CI, 0.4-1.6 months) in patients who were managed with BSC,  < 0.001; hazard ratio, 0.39 (95% CI, 0.27-0.56). The disease stage, lactate dehydrogenase level, and receipt of chemotherapy significantly impacted survival.

Conclusion: Chemotherapy prolongs survival in patients with SCLC and poor PS. Administering an initial attenuated chemotherapy regimen followed by standard full-dose chemotherapy when the PS improves may lower toxicity and improve tolerance.
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http://dx.doi.org/10.1080/0284186X.2020.1819562DOI Listing
December 2020

Thromboembolic events in brain tumour patients on bevacizumab.

Acta Oncol 2020 Dec 8;59(12):1543-1546. Epub 2020 Sep 8.

Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.

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http://dx.doi.org/10.1080/0284186X.2020.1815834DOI Listing
December 2020

Low-cost oral metronomic chemotherapy versus intravenous cisplatin in patients with recurrent, metastatic, inoperable head and neck carcinoma: an open-label, parallel-group, non-inferiority, randomised, phase 3 trial.

Lancet Glob Health 2020 09;8(9):e1213-e1222

Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.

Background: Regimens for palliation in patients with head and neck cancer recommended by the US National Comprehensive Cancer Network (NCCN) have low applicability (less than 1-3%) in low-income and middle-income countries (LMICs) because of their cost. In a previous phase 2 study, patients with head and neck cancer who received metronomic chemotherapy had better outcomes when compared with those who received intravenous cisplatin, which is commonly used as the standard of care in LMICs. We aimed to do a phase 3 study to substantiate these findings.

Methods: We did an open-label, parallel-group, non-inferiority, randomised, phase 3 trial at the Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India. We enrolled adult patients (aged 18-70 years) who planned to receive palliative systemic treatment for relapsed, recurrent, or newly diagnosed squamous cell carcinoma of the head and neck, and who had an Eastern Cooperative Oncology Group performance status score of 0-1 and measurable disease, as defined by the Response Evaluation Criteria In Solid Tumors. We randomly assigned (1:1) participants to receive either oral metronomic chemotherapy, consisting of 15 mg/m methotrexate once per week plus 200 mg celecoxib twice per day until disease progression or until the development of intolerable side-effects, or 75 mg/m intravenous cisplatin once every 3 weeks for six cycles. Randomisation was done by use of a computer-generated randomisation sequence, with a block size of four, and patients were stratified by primary tumour site and previous cancer-directed treatment. The primary endpoint was median overall survival. Assuming that 6-month overall survival in the intravenous cisplatin group would be 40%, a non-inferiority margin of 13% was defined. Both intention-to-treat and per-protocol analyses were done. All patients who completed at least one cycle of the assigned treatment were included in the safety analysis. This trial is registered with the Clinical Trials Registry-India, CTRI/2015/11/006388, and is completed.

Findings: Between May 16, 2016, and Jan 17, 2020, 422 patients were randomly assigned: 213 to the oral metronomic chemotherapy group and 209 to the intravenous cisplatin group. All 422 patients were included in the intention-to-treat analysis, and 418 patients (211 in the oral metronomic chemotherapy group and 207 in the intravenous cisplatin group) were included in the per-protocol analysis. At a median follow-up of 15·73 months, median overall survival in the intention-to-treat analysis population was 7·5 months (IQR 4·6-12·6) in the oral metronomic chemotherapy group compared with 6·1 months (3·2-9·6) in the intravenous cisplatin group (unadjusted HR for death 0·773 [95% CI 0·615-0·97, p=0·026]). In the per-protocol analysis population, median overall survival was 7·5 months (4·7-12·8) in the oral metronomic chemotherapy group and 6·1 months (3·4-9·6) in the intravenous cisplatin group (unadjusted HR for death 0·775 [95% CI 0·616-0·974, p=0·029]). Grade 3 or higher adverse events were observed in 37 (19%) of 196 patients in the oral metronomic chemotherapy group versus 61 (30%) of 202 patients in the intravenous cisplatin group (p=0·01).

Interpretation: Oral metronomic chemotherapy is non-inferior to intravenous cisplatin with respect to overall survival in head and neck cancer in the palliative setting, and is associated with fewer adverse events. It therefore represents a new alternative standard of care if current NCCN-approved options for palliative therapy are not feasible.

Funding: Tata Memorial Center Research Administration Council.

Translations: For the Hindi, Marathi, Gujarati, Kannada, Malayalam, Telugu, Oriya, Bengali, and Punjabi translations of the abstract see Supplementary Materials section.
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http://dx.doi.org/10.1016/S2214-109X(20)30275-8DOI Listing
September 2020

Concomitant use of antibiotics and immune checkpoint inhibitors in patients with solid neoplasms: retrospective data from real-world settings.

Ecancermedicalscience 2020 8;14:1038. Epub 2020 May 8.

Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, 400012, India.

Background: The use of antibiotics is known to alter the gut microbiome and it is hypothesised that the use of antibiotics may also alter the response to immune checkpoint inhibitors (ICI). As data is limited from real-world settings, we performed a retrospective audit of patients who received ICI along with concomitant antibiotics.

Patients And Methods: This study is a retrospective audit of a prospectively collected the database of patients who received ICI for advanced solid tumours in any line between August 2015 and November 2018 at Tata Memorial Hospital, Mumbai, India. Antibiotic use was recorded from 2 weeks before the start of ICI and concomitantly with ICI. All statistical calculations were performed using Statistical Package for the Social Sciences (SPSS) statistical software for windows version 20.0.

Results: A total of 155 patients were identified as having received ICI during the study period, out of which 70 (44%) patients received antibiotics. Median PFS in patients who received antibiotics was 1.7 months (95% CI: 1.1-2.3) as against 3.6 months (95% CI: 2.3-4.8) for patients who did not receive antibiotics ( = 0.912). Median OS in the patients who received antibiotics was 3.9 months (95% CI: 1.8-11.4) as compared to 9.2 months (95% CI: 4.2-12.3) who did not receive antibiotics = 0.053 (HR = 1.023; 95% CI: 1.00-1.04). Among the patients who received antibiotics, median OS for patients who received ≤10 days of antibiotics was 8.8 months (95% CI: 4.2-11.2) while for patients receiving >10 days of antibiotics, it was 2.8 months (95% CI: 1.2-4.4), = 0.025 (HR = 2.0, 95% CI: 1.1-3.7). Thirty-three (21.2% of total) patients received antibiotics during the window of 2 weeks before the start of ICI to 2 months of starting ICI. Median OS in the patients who received antibiotics in this window was 2.8 months (95% CI: 1.2-4.5) as compared to 9.2 months (95% CI: 5.2-13.1) who did not receive antibiotics = 0.008 (HR = 1.8; 95%CI: 1.2-3.0).

Conclusions: This study shows that the judicious use of antibiotics is required in patients on ICI or scheduled to be started on ICI.
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http://dx.doi.org/10.3332/ecancer.2020.1038DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7289608PMC
May 2020
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