Publications by authors named "Guillaume Mouillet"

28 Publications

  • Page 1 of 1

Feasibility of health-related quality of life (HRQoL) assessment for cancer patients using electronic patient-reported outcome (ePRO) in daily clinical practice.

Qual Life Res 2021 Jan 2. Epub 2021 Jan 2.

Methodological and Quality of Life Unit in Oncology, University Hospital of Besançon, 25000, Besançon, France.

Introduction: Routine Electronic Monitoring of Health-Related Quality of Life (HRQoL) (REMOQOL) in clinical care with real-time feedback to physicians could help to enhance patient-centered care. We evaluated the feasibility of REMOQOL in the French context in the QOLIBRY study. The primary objective was to assess the patients' compliance with REMOQOL.

Methods: The QOLIBRY study was a single-center, prospective study conducted in the University Hospital of Besançon (France). Eligible patients were those treated with systemic therapies for breast, lung or colorectal cancer at any stage. Patients were invited to complete the EORTC QLQ-C30 questionnaire and cancer-site-specific modules before each visit on tablets and/or computers in the hospital or at home. During the consultation, physicians had real-time access to visual summaries of HRQoL scores. Compliance was assessed as adequate if at least 66% of HRQoL assessments were completed during the 4 months of follow-up.

Results: Between March 2016 and October 2018, 177 patients were included in the QOLIBRY study. Median age was 64 years (IQR 54-71). The proportion of patients with an adequate compliance rate was 95.5% (n = 63) in the breast cancer cohort, 98.2% (n = 55) in the colorectal cancer cohort, and 90.9% (n = 50) in the lung cancer cohort. The physicians checked the HRQoL results in 73.1% of visits and prescribed supportive care and adapted patient management in 8.3% and 5.2% of visits, respectively.

Conclusion & Perspectives: The results of QOLIBRY study suggest that REMOQOL is feasible in the French context. However, information about HRQoL monitoring, training of the physicians in the use of the software, and recommendations for using HRQoL results to guide care are essential and must be improved.
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http://dx.doi.org/10.1007/s11136-020-02721-0DOI Listing
January 2021

Investigating the impact of open label design on patient-reported outcome results in prostate cancer randomized controlled trials.

Cancer Med 2020 Oct 26;9(20):7363-7374. Epub 2020 Aug 26.

Methodological and Quality of Life Unit in Oncology, University Hospital of Besançon, Besançon, France.

Background: While open-label randomized controlled trials (RCT) are common in oncology, some concerns have been expressed with regard to Patient-Reported Outcomes (PRO)-based claims stemming from these studies. We aimed to investigate the impact of open-label design in the context of prostate cancer (PCa) RCTs with PRO data.

Methods: Randomized controlled trials of PCa with a PRO endpoint published between 2004 and 2018 were considered. RCTs were systematically evaluated on the basis of previously defined criteria, including international PRO reporting quality standards and the Cochrane Collaboration's tool for assessing Risk of Bias. The rate of concordance was estimated and compared between traditional clinical outcomes (eg, survival or tumor response) and PRO in open and blinded RCTs.

Results: We identified 110 RCTs published between 2004 and 2018, of which 62% (n = 68) were open-label. The general characteristics of PCa RCTs were not different according to their design (open-label vs blinded). The proportion of PCa RCTs with high-quality PRO reporting was not different between open-label RCTs and blinded RCTs (41.2% vs 38.1%; P = .75). No statistically significant difference was found between PRO results and concordance with traditional clinical outcomes according to the study design.

Conclusion: Our findings suggest that there is no evidence of significant bias for PROs due to the absence of blinding in the context of PCa RCTs. Further analyses should be conducted in other cancer disease sites.
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http://dx.doi.org/10.1002/cam4.3335DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7571808PMC
October 2020

Activity and tolerability of maintenance avelumab immunotherapy after first line polychemotherapy including platinum in patients with locally advanced or metastatic squamous cell penile carcinoma: PULSE.

Bull Cancer 2020 Jun;107(5S):eS16-eS21

Oncologie médicale, Centre Hospitalier Universitaire, Besançon, 25030 Besançon cedex, France; / Medical Oncology, University Hospital, Besançon, France; INSERM, UMR1098, Besançon, France.

Background Metastatic Squamous cell Penile Carcinoma (mSCPC) is an orphan disease with a virally induced oncogenesis. PD-L1 expression rate is around 60% with a strong correlation between PD-L1 in the primary tumour and metastases. The first line systemic treatment relies on platinum-based chemotherapies with a median progression free survival and overall survival around 7.5 and 16 months, respectively. Immunotherapies targeting PD-1/PD-L1 axis are effective in other squamous cell or HPV related cancers. Methods PULSE is a prospective multicenter open label single arm phase II study. Thirty-two patients will be enrolled after a radiological assessment showing a non-progressive disease after 3 to 6 cycles of a first line platinum-based polychemotherapy. Patients will receive Avelumab injections 10mg/ kg every two weeks until progression or unacceptable toxicity. The primary endpoint will be the progression free survival (PFS) according to RECIST v1.1 criteria. Secondary endpoints will include PFS according to iRECIST criteria, overall survival, quality of life, safety. Ancillary explorations will include assessing blood and tissue biomarkers for association with clinical benefit. Discussion After the first line, the prognosis remains poor with no consensus on a second line systemic treatment in locally advanced or mSCPC. PULSE trial is the first study that assess an anti PD-L1 immunotherapy in maintenance among patients with locally advanced or mSCPC. NCT NUMBER : NCT03774901.
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http://dx.doi.org/10.1016/S0007-4551(20)30282-4DOI Listing
June 2020

[Systemic treatment of locally advanced or metastatic penile cancer].

Bull Cancer 2020 Jun;107(5S):S17-S23

CHU de Besançon, oncologie, 25030 Besançon cedex, France; CHU de Besançon, oncologie, 25030 Besançon cedex, France; Inserm, UMR1098, 25020 Besançon cedex, France.

Penile cancers are rare, the vast majority is represented by squamous cell carcinoma, with HPV virus being found in 30 to 40% of cases. At a locally advanced or metastatic stage, first-line treatment relies on platinum and taxane based polychemotherapy. The prognosis for advanced or metastatic penile cancer remains poor, with overall survival ranging from 13.9 to 17.1 months. After the first line, guidelines recommend various chemotherapy treatments or targeted anti-EGFR therapies whose results as well as the level of evidence are limited. A better understanding of the oncogenic pathways involved in penile cancer and a frequent expression of PD-L1 are the rationale for the elaboration of new strategies. This review article presents the data, guidelines and ongoing studies in locally advanced or metastatic penile cancer.
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http://dx.doi.org/10.1016/S0007-4551(20)30274-5DOI Listing
June 2020

Targeted and immune therapies among patients with metastatic renal carcinoma undergoing hemodialysis: A systemic review.

Semin Oncol 2020 Apr - Jun;47(2-3):103-116. Epub 2020 May 26.

Department of Medical Oncology, CHRU Jean Minjoz, Besançon cedex, France; Université de Franche-Comté, Besançon cedex, France; INSERM, Besançon cedex France.

Background: Patients with severe renal impairment or undergoing hemodialysis are usually excluded from clinical trials. Available data regarding safety and activity of systemic therapies (ST) in hemodialyzed patients are scarce.

Methods: Clinical data were searched through PubMed database until April 2020 according to PRISMA criteria. Efficacy, safety and pharmacokinetic (PK) assessment of ST were reported.

Results: Among 270 references, 56 reports were evaluated in full text: 41 were included for efficacy and 42 for safety analysis (sunitinib n = 68, bevacizumab n = 6, everolimus n = 28, temsirolimus n = 17, sorafenib n = 55, axitinib n = 13, pazopanib n = 13, nivolumab n = 18, cabozantinib n = 0, lenvatinib n = 0, and ipilimumab n = 0). Twelve of the reports included PK assessment among dialyzed patients. Hemodialysis did not seem to modify the expected efficacy and safety of each compound among patients undergoing hemodialysis. PK assessments were not modified in comparison with a population not undergoing dialysis.

Conclusion: Targeted and Immune therapies seem to be effective and can be used among patients undergoing hemodialysis. Due to frailty and comorbidities associated to chronic hemodialysis enhanced vigilance for these therapies within this specific population is recommended. Dedicated prospective clinical trials would definitely help to obtain data with a higher level of evidence.
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http://dx.doi.org/10.1053/j.seminoncol.2020.05.001DOI Listing
January 2021

Metronomic cyclophosphamide induces regulatory T cells depletion and PSA-specific T cells reactivation in patients with biochemical recurrent prostate cancer.

Int J Cancer 2020 Aug 11;147(4):1199-1205. Epub 2019 Dec 11.

Université de Bourgogne Franche-Comté, INSERM, EFS BFC, UMR1098, Interactions Hôte-Greffon-Tumeur/Ingénierie Cellulaire et Génique, Besançon, France.

Biochemical recurrence (BCR) occurs in up to 40% of prostate cancer patients after prostatectomy. In our study, we performed an immune monitoring study in 20 prostate cancer patients with BCR previously treated with metronomic cyclophosphamide (mCTX). We observed a decrease of regulatory T cells (Tregs) from 2 months and this was more pronounced after 6 months of mCTX treatment. This drop of Tregs was associated with increased level of activated HLADR CD45R0 T cells in peripheral blood. Furthermore, a reactivation of Th1 polarized anti-PSA T-cell response was detected in BCR patients treated with mCTX. However, dendritic cell subsets counts and activation were not influenced by the treatment. In the clinical setting, we found that PSA level control was observed in 82% (9/11) of patients with a significant diminution of Tregs after mCTX compared to 33% (3/9) in patients without Tregs decrease. In addition, 30% (6/20) of patients previously treated with mCTX remained free for androgen deprivation therapy. In conclusion, Tregs diminution and immune activation associated with PSA level control occurred after mCTX in prostate cancer patients with BCR.
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http://dx.doi.org/10.1002/ijc.32803DOI Listing
August 2020

[Relapse surveillance of patients with testicular germ cell tumor].

Bull Cancer 2019 Oct 5;106(10):903-914. Epub 2019 Sep 5.

CHU de Besançon, oncologie, 25030 Besançon cedex, France; Inserm, UMR1098, 25020 Besançon cedex, France; Université de Franche-Comté, UMR1098, SFR IBCT, 25020 Besançon, France.

Germ-cell tumors are the most common solid tumors in young men. The follow-up of these patients is very important in their management. In stage I testicular cancer, surveillance is the standard for low-risk disease. In addition to the early detection of relapse, follow-up should be directed towards prevention, detection and treatment of late toxicity, and secondary malignancies. Follow up consists in physical examination, laboratory analysis and radiological imaging. Recently, guidelines recommend risk-adapted surveillance strategy, with a reduction of CT scans numbers, due to the recognition of the risk of ionizing radiation exposure. However, efforts to maintain adequate compliance with follow up are required.
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http://dx.doi.org/10.1016/j.bulcan.2019.06.006DOI Listing
October 2019

[Sexual dysfunctions of patients treated with orchidectmoy, chemotherapy and retroperitoneal lymphadenectomy, need for systematic andrological care?]

Bull Cancer 2019 Oct 22;106(10):915-922. Epub 2019 May 22.

Centre hospitalier universitaire, Hôtel-Dieu, service d'urologie, 44000 Nantes, France.

Goal: Long-term evaluation of the incidence of sexual dysfunction from patients who were treated by orchidectomy, chemotherapy, and retroperitoneal lymphadenectomy for testicular cancer.

Methods: In 2018, patients who were treated in two academic hospitals by orchiectomy, chemotherapy, and retroperitoneal lymphadenectomy, and were in complete remission, were included. The patients included in this study filled the survey, which covered aspects of their sexuality (the Male Sexual Health Questionnaire) and answered additional questions, which evaluated psychological impact and modification of their sexuality since the management of their cancer.

Results: Twenty patients have been included, 70% of the patients treated for non-seminomatous germ cell tumor. Mean age was 36.4years±12.1 and the average duration of follow-up was 59months±34. Sexual dysfunction was found in 50% of the patients. Only 10% of the patients could preserve satisfying sexual activity during their treatment. Since the end of their treatment, 16%, 21% and 37% of patients respectively declared high libido loss, lower tumescent erections and persistence of anejaculation. In the end, nearly 70% of these patients wished a dedicated consultation with an urologist with subspecialty in andrology, in order to obtain further information during their care course.

Discussion: These patients have shown multicomponent sexual dysfunction. They could benefit from a new healthcare pathway implying early involvement of andrologist network.
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http://dx.doi.org/10.1016/j.bulcan.2019.03.020DOI Listing
October 2019

Health-related quality of life assessment for patients with advanced or metastatic renal cell carcinoma treated with a tyrosine kinase inhibitor using electronic patient-reported outcomes in daily clinical practice (QUANARIE trial): study protocol.

Health Qual Life Outcomes 2019 Feb 4;17(1):25. Epub 2019 Feb 4.

Department of Medical Oncology, University Hospital of Besançon, Boulevard Fleming, F-25000, Besançon, France.

Background: Two main therapies, pazopanib and sunitinib, are used in the first-line setting for metastatic renal cell carcinoma (mRCC). These two tyrosine kinase inhibitors (TKI) are equally effective in terms of survival; however, they frequently induce adverse events. In this setting, Health-Related Quality of life (HRQoL) is a key element in the choice between these two treatments and the evaluation of treatment effectiveness. It could be of interest to evaluate HRQoL in daily clinical practice to aid adequate therapy choice and management. Currently, the development of information and communication technology may allow HRQoL monitoring in routine practice. The objective of the QUANARIE study is to evaluate the use of HRQoL assessment in daily clinical practice for patients with mRCC treated with TKI using electronic patient-reported outcomes (e-PRO). The present article describes the key elements of the study protocol.

Methods: The QUANARIE study is an interventional, prospective, multicentre trial. Patients diagnosed with mRCC initiating sunitinib or pazopanib treatment will be invited to complete the EORTC QLQ-C30 questionnaire, nine additional questions from the EORTC items library, and the EuroQoL EQ-5D, prior to each visit with the physician. Questionnaires will be completed by patients using tablets and/or computer terminals via the e-PRO software. The physician will have real-time access to a visual summary of the HRQoL evaluation. The primary objective is to assess the proportion of patients having good compliance with Routine Electronic Monitoring of HRQoL (REMOQOL) during the first 12 months. Physicians' satisfaction with REMOQOL will be assessed as a secondary objective. We hypothesise that 80% of patients having good compliance with REMOQOL would be meaningful. A sample size of 56 patients would be needed.

Discussion: The results of this study will show whether REMOQOL is feasible on a large scale and whether patients are receptive to this new practice. This study will also determine how real-time multidimensional evaluation of patient perception can help physicians in their daily practice and how they used it in conjunction with other clinical information to manage patient care.

Trial Registration: ClinicalTrials.gov; Identifier: NCT03062410 ; First Posted: February 23, 2017; Last Update Posted: August 9, 2017.
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http://dx.doi.org/10.1186/s12955-019-1085-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6360763PMC
February 2019

Second-line targeted therapies after nivolumab-ipilimumab failure in metastatic renal cell carcinoma.

Eur J Cancer 2019 02 5;108:33-40. Epub 2019 Jan 5.

Medical Oncology, Gustave Roussy, Université Paris-Saclay, Villejuif, France. Electronic address:

Background: Nivolumab-ipilimumab demonstrated a survival benefit over sunitinib in first-line setting for metastatic renal cell carcinomas (mRCCs) and is becoming a new standard of care for naïve patients with intermediate or poor risk prognosis (International mRCC Database Consortium). The efficacy of subsequent vascular endothelial growth factor receptor tyrosine kinase inhibitors (TKIs) after nivolumab-ipilimumab failure remains unclear.

Methods: Medical records of mRCC patients treated with nivolumab-ipilimumab, who received subsequent TKI, as part of Checkmate 214 study were reviewed in 13 institutions. Baseline characteristics, outcome data including progression-free survival (PFS), response, overall survival (OS) and toxicities were retrospectively collected.

Results: Overall 33 patients received subsequent TKI after nivolumab-ipilimumab failure. Median follow-up from start of subsequent TKI is 22 months (19-NR). Best response was assessed in 30 patients: 12 partial responses (36%), 13 stable diseases (39%) and five progressive diseases (15%). Median PFS from start of TKI was 8 months [5-13]. Median PFS with first-generation (sunitinib/pazopanib) and second-generation TKI (axitinib/cabozantinib) was 8 months [5-16] and 7 months (5-NA), respectively. PFS in second line was significantly longer in patients with a long first-line duration of response to the double immune checkpoint blockade (≥6 months) with 8 versus 5 months for short responder (<6 months) (p = 0.03). OS rate was 54% at 12 months. Toxicity was as expected: 42% developed at least one toxicity grade ≥3.

Conclusion: This is the first report of outcomes with TKI, after first-line nivolumab-ipilimumab failure. Median PFS suggests a sustained benefit of TKI and supports trials investigating the optimal sequence.
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http://dx.doi.org/10.1016/j.ejca.2018.11.031DOI Listing
February 2019

Economic Burden of Metastatic Clear-Cell Renal Cell Carcinoma for French Patients Treated With Targeted Therapies.

Clin Genitourin Cancer 2019 Feb 7;17(1):e227-e234. Epub 2018 Nov 7.

Department of Pharmacy, University Hospital, Besançon, France; INSERM, EFS BFC, UMR1098, Interactions hôte-greffon-tumeur, Ingénierie Cellulaire et Génique, University Bourgogne Franche-Comté, Besançon, France. Electronic address:

Background: Targeted therapies have transformed the treatment of metastatic clear-cell renal cell carcinoma (mccRCC). Despite the importance of mccRCC, studies on its economic burden in daily practice are sparse. The purpose of this retrospective study was to evaluate cost of illness for 224 patients with mccRCC included in the cohort published by Thiery-Vuillemin et al (Factors influencing overall survival for patients with metastatic clear-cell renal cell-carcinoma in daily practice. Clin Genitourin Cancer 2018; 16:e297-305), and then to determine the explanatory factors of cost of illness.

Patients And Methods: The study was performed from the French Public Healthcare System perspective with lifetime horizon. Only direct medical costs were included. Multiple linear regression was used to search for explanatory factors of cost of illness. The robustness of results was assessed.

Results: The mean cost of illness was estimated at €71,185 ± 52,683. Outpatient/inpatient treatment and hospitalization represented 76.0% and 19.7% of this cost, respectively. After adjustment, 5 explanatory factors were identified: time of disease control for the metastatic first-line treatment ≥6 months, number of lines of treatment >2, nephrectomy at metastatic stage, lack of metastases at presentation, and age at metastatic diagnosis younger than 65 years. Individually, they increased cost of illness by 128%, 95%, 53%, 53%, and 23%, respectively.

Conclusion: Although it is difficult to transpose our economic evaluation results to those obtained in other countries, it should be noted that our findings were consistent with them and robust. To our knowledge, our study was the first to accurately identify explanatory factors of cost of illness. Identifying them could enable us to predict the budgetary effect on a regional level of managing patients who began their first-line treatment with a targeted therapy.
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http://dx.doi.org/10.1016/j.clgc.2018.10.016DOI Listing
February 2019

Open-label, randomized multicentre phase II study to assess the efficacy and tolerability of sunitinib by dose administration regimen (dose modification or dose interruptions) in patients with advanced or metastatic renal cell carcinoma: study protocol of the SURF trial.

Trials 2018 Apr 12;19(1):221. Epub 2018 Apr 12.

Department of Medical Oncology, University Hospital of Besançon, 25000, Besancon, France.

Background: Sunitinib is a tyrosine kinase inhibitor approved in the first-line metastatic renal cell carcinoma (MRCC) setting at the dose of 50 mg daily for 4 weeks followed by a pause of 2 weeks. Due to toxicity, this standard schedule (50 mg daily 4/2) can induce up to 50% of sunitinib dose modification (reduction and/or interruption). The current recommendation in such case is to reduce the dose to 37.5 mg per day (standard schedule 4/2). Recent data highlight an alternative schedule: 2 weeks of treatment followed by 1 week of pause (experimental schedule 2/1). The SURF trial is set up to evaluate prospectively experimental schedule 2/1 when toxicity occurs. This article displays the key elements of the study protocol.

Methods/design: SURF [NCT02689167] is a prospective, randomized, open-label phase IIb study. Patients are included at sunitinib initiation while receiving standard schedule 4/2 (50 mg daily) according to the marketing authorization indication. When a dose adjustment of sunitinib is required, patients are randomized between standard schedule 4/2 (37.5 mg daily) and experimental schedule 2/1 (50 mg daily). Key eligibility criteria are the following: patients with locally advanced inoperable or MRCC who are starting first-line treatment with sunitinib, with histologically or cytologically confirmed renal cancer clear cell variant or with a clear cell component, and with Karnofsky performance status ≥70%. The primary objective is to assess the median duration of sunitinib treatment (DOT) in each group. The key secondary objectives are progression-free survival, overall survival, time to randomization, objective response rate, safety, sunitinib dose intensity, health-related quality of life, and the description of main drivers triggering randomization. We hypothesized that experimental schedule 2/1 would result in an improvement in median DOT from 6 to 8.5 months. It was estimated that 112 patients would be needed in each arm during 24 months. In order to take into account the possibility of treatment discontinuation before randomization, 248 patients are necessary.

Discussion: The SURF trial is asking a pragmatic question adapted to the current practice on what is the best way to adapt sunitinib when treatment-related adverse events occur. The results of the SURF trial will bring high-value data to support the use of an alternative schedule in sunitinib treatment.

Trial Registration: ClinicalTrials.gov, NCT02689167 . Registered on 26 February 2016.
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http://dx.doi.org/10.1186/s13063-018-2613-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5898055PMC
April 2018

Testicle-sparing surgery versus radical orchiectomy in the management of Leydig cell tumors: results from a multicenter study.

World J Urol 2018 Mar 11;36(3):427-433. Epub 2017 Dec 11.

Department of Urology and Renal Transplantation, University Hospital of Besancon, 3 Boulevard Fleming, 25000, Besancon, France.

Objective: To compare the oncological outcomes of testicle-sparing surgery (TSS) and radical orchiectomy (RO) in patients with Leydig cell tumor (LCT) of the testis.

Patients And Methods: A multicenter retrospective clinical study was conducted in 12 centers in France. All the patients with histologically proven LCT were included and analyzed according to treatment (organ-sparing surgery or radical orchiectomy). Patients underwent preoperative clinical, biological and imaging assessment. Demographic, clinical, and pathological variables were collected at baseline and compared between groups according to surgical treatment. Follow-up was calculated using the reverse Kaplan-Meier estimation and was updated at the end of 2015.

Results: Between 1986 and 2014, 56 patients presented with LCT were identified and included in the study. Twenty-one patients (37.5%) underwent TSS and 35 (62.5%) RO. Demographics and tumor characteristics were not significantly different between the groups. Median follow-up was 62 months after TSS, but only 35 months after RO. Two patients (9.5%) developed local recurrence 15 and 34 months after TSS and underwent secondary RO. No local recurrence or metastasis was observed after complementary treatment. No recurrence was observed after RO. Disease-free survival did not differ between the groups (95.2% in TSS versus 77.1% in the RO group, p = 0.23). No patient died in the TSS group, but three patients (8.6%) in the RO group died from other diseases without evidence of relapse. One patient (4.8%) in the TSS group versus five (14.3%) in the RO group were lost to follow-up.

Conclusion: Long-term follow-up suggests that testicle-sparing surgery does not compromise relapse-free survival in the treatment of Leydig cell tumor of the testis.
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http://dx.doi.org/10.1007/s00345-017-2151-0DOI Listing
March 2018

Factors Influencing Overall Survival for Patients With Metastatic Clear-Cell Renal-Cell Carcinoma in Daily Practice.

Clin Genitourin Cancer 2018 04 25;16(2):e297-e305. Epub 2017 Sep 25.

Department of Pharmacy, University Hospital, Besançon, France; University Bourgogne Franche-Comté, INSERM, EFS BFC, UMR1098, Interactions hôte-greffon-tumeur, Ingénierie Cellulaire et Génique, Besançon, France. Electronic address:

Purpose: To describe factors associated with overall survival (OS) among patients with metastatic clear-cell renal-cell carcinoma (mccRCC) in regard to evolution of systemic therapies.

Patients And Methods: Two hundred twenty-four consecutive patients with histologically confirmed mccRCC who received targeted therapy on first-line treatment between January 2007 and March 2015 were included. The primary end point was OS for metastatic first-line or second-line treatment. An analysis of prognostic factors of long survival was performed using a 2-step approach: univariate, then multivariate analysis.

Results: Median OS [95% confidence interval] was 19.4 months [16.1-24.9]. Three prognostic factors were identified in first-line treatment: Memorial Sloan Kettering Cancer Center (MSKCC) favorable and intermediate risks (hazard ratio [95% confidence interval] = 0.362 [0.207-0.630] and 0.561 [0.393-0.801], respectively, P = 4.10), metastasectomy (0.667 [0.468-0.951], P = .03), and lack of lymph node metastasis (0.715 [0.513-0.994], P = .049). In second-line treatment, median OS [95% confidence interval] was 11.0 months [8.9-14.4] for 167 patients. Three different prognostic factors predicted long survival: toxicity for first-line treatment discontinuation (HR [95% confidence interval] = 0.298 [0.180-0.493], P < 10), duration of disease control in first-line therapy (0.961 [0.942-0.979], P = 2.10), and MSKCC favorable and intermediate risks (0.461 [0.252-0.843] and 0.936 [0.607-1.443], respectively, P = .02).

Conclusion: These real-life data confirm the positive impact of targeted therapy in the mccRCC setting. Moreover, it emphasizes the importance of considering many factors in order to better estimate prognosis in patient pretreated with systemic therapy.
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http://dx.doi.org/10.1016/j.clgc.2017.09.006DOI Listing
April 2018

Mutation in BRAF V600E: A Poor Prognostic Marker in Stage III Colon Cancers With Deficient MMR?

JAMA Oncol 2017 09;3(9):1284-1285

Department of Medical Oncology, Poitiers University Hospital, Poitiers, France.

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http://dx.doi.org/10.1001/jamaoncol.2017.0262DOI Listing
September 2017

Hemodialysis does not impact axitinib exposure: clinical case of a patient with metastatic renal cell carcinoma.

Cancer Chemother Pharmacol 2017 Jun 27;79(6):1273-1276. Epub 2017 Apr 27.

INSERM, UMR1098, 25020, Besançon cedex, France.

Axitinib is approved with indication in patients with advanced renal cell carcinoma (RCC). Due to the localization of this cancer, physicians sometimes have to deal with hemodialyzed patients. Data exploring hemodialysis (HD) impact on axitinib pharmacokinetic (PK) or safety are lacking. To date, no data have been published on that problematic. This is the first publication discussing the assessment of axitinib PK for a patient undergoing HD. Our results suggest that there is no influence of HD on axitinib blood concentration. Interestingly, the membranes used are common and represent around 90% of the membranes used in routine for HD. Our data are also reassuring both from activity and from safety perspectives. In that case, axitinib administered at a dose of 6 mg twice a day was well tolerated and allowed 12 months of disease control. These results are in line with previous publications discussing other anti-angiogenic tyrosine kinase inhibitors pharmacokinetics, safety and activity among patients with metastatic RCC undergoing hemodialysis.
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http://dx.doi.org/10.1007/s00280-017-3320-yDOI Listing
June 2017

[Assessment of the quality of life with regard to health following a cancer diagnosis].

Rev Infirm 2017 Jan;66(227):36-37

Methodological and Quality of Life Unit in Oncology (INSERM UMR 1098) CHRU Besançon, Jean-Minjoz, 3 boulevard Fleming, 25 030 Besançon, France.

The measurement of the quality of life in terms of health of people undergoing treatment for cancer is developing. This new indicator focusing on patients' personal experience is combined with standard criteria relating to their tumours. The data are also a factor in the prognosis of overall survival. A team of researchers at Besançon university hospital shares its experience.
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http://dx.doi.org/10.1016/j.revinf.2016.11.013DOI Listing
January 2017

[Prevalence and management of pain in patients with metastatic cancer in Franche-Comté].

Bull Cancer 2016 Oct 29;103(10):849-860. Epub 2016 Sep 29.

CHRU de Besançon, pôle pharmacie, 3, boulevard Alexandre-Fleming, 25030 Besançon cedex, France; Université Bourgogne Franche-Comté, INSERM, EFS BFC, UMR1098, interactions hôte-greffon-tumeur - ingénierie cellulaire et génique, Besançon, France. Electronic address:

Introduction: Pain management is a major public health problem, especially in oncology. In order to assess professional practice, the IRFC-FC conducted a survey amongst patients with metastatic osteophilic solid tumor in Franche-Comté. The aims were to assess the pain prevalence, and its characteristics, its management and its impact on patients' quality of life in patients in pain.

Methods: An observational, prospective and multicenter survey was conducted using a self-report questionnaire. Patients with metastatic breast or prostate cancer managed in 5 day-hospitals of the IRFC-FC over a period of three months were included.

Results: Two hundred thirty-three questionnaires were analyzed. Pain prevalence rate was 48.5%. Three quarters of patients in pain had chronic background pain, moderate to severe, with or without breakthrough pain. Considering their pain intensity and their analgesic therapy, 42.0% of patients seem to have an inadequate treatment. Eighty-five percent of treated patients reported to be compliant and felt that their pain was well managed despite a strong impact on their quality of life.

Conclusion: The setting of a specific clinical pathway is essential to secure the standardized, optimal and efficient management of patients in pain. The assessment of patient satisfaction and quality of life must be integrated in clinical practice to identify patients in pain for which the treatment is inappropriate.
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http://dx.doi.org/10.1016/j.bulcan.2016.08.007DOI Listing
October 2016

Age, Neurological Status MRC Scale, and Postoperative Morbidity are Prognostic Factors in Patients with Glioblastoma Treated by Chemoradiotherapy.

Clin Med Insights Oncol 2016 17;10:77-82. Epub 2016 Aug 17.

Department of Medical Oncology, University Hospital Jean Minjoz, Besançon cedex, France.; University of Franche-Comté, UMR1098, SFR IBCT, Besançon, France.; INSERM UMR1098, Besançon, France.

Introduction: Temozolomide and concomitant radiotherapy followed by temozolomide has been used as a standard therapy for the treatment of newly diagnosed glioblastoma multiform since 2005. A search for prognostic factors was conducted in patients with glioblastoma routinely treated by this strategy in our institution.

Methods: This retrospective study included all patients with histologically proven glioblastoma diagnosed between June 1, 2005, and January 1, 2012, in the Franche-Comté region and treated by radiotherapy (daily fractions of 2 Gy for a total of 60 Gy) combined with temozolomide at a dose of 75 mg/m(2) per day, followed by six cycles of maintenance temozolomide (150-200 mg/m(2), five consecutive days per month). The primary aim was to identify prognostic factors associated with overall survival (OS) in this cohort of patients.

Results: One hundred three patients were included in this study. The median age was 64 years. The median OS was 13.7 months (95% confidence interval, 12.5-15.9 months). In multivariate analysis, age over 65 years (hazard ratio [HR] = 1.88; P = 0.01), Medical Research Council (MRC) scale 3-4 (HR = 1.62; P = 0.038), and occurrence of postoperative complications (HR = 2.15; P = 0.028) were associated with unfavorable OS.

Conclusions: This study identified three prognostic factors in patients with glioblastoma eligible to the standard chemotherapy and radiotherapy treatment. Age over 65 years, MRC scale 3-4, and occurrence of postoperative complications were associated with unfavorable OS. A simple clinical evaluation including these three factors enables to estimate the patient prognosis. MRC neurological scale could be a useful, quick, and simple measure to assess neurological status in glioblastoma patients.
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http://dx.doi.org/10.4137/CMO.S38474DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4990148PMC
August 2016

Metronomic cyclophosphamide therapy in hormone-naive patients with non-metastatic biochemical recurrent prostate cancer: a phase II trial.

Med Oncol 2016 Aug 11;33(8):89. Epub 2016 Jul 11.

Department of Medical Oncology, CHRU Minjoz, Besançon, France.

After curative local therapy, biochemical recurrence is a mode of relapse among patient with prostate cancer (PC). Deferring androgen deprivation therapy (ADT) or offering non-hormonal therapies may be an appropriate option for these non-symptomatic patients with no proven metastases. Metronomic cyclophosphamide (MC) has shown activity in metastatic PC setting and was chosen to be assessed in biochemical relapse. This prospective single-arm open-label phase II study was conducted to evaluate MC regimen in patients with biochemical recurrent PC. MC was planned to be administered orally at a daily dose of 50 mg for 6 months. Primary endpoint was PSA response. Thirty-eight patients were included and treated. Median follow-up was 45.5 months (range 17-100). Among them, 14 patients (37 %) achieved PSA stabilisation and 22 patients (58 %) experienced PSA progression. Response rate was 5 % with one complete response (2.6 %), and 1 partial response with PSA decrease >50 % (2.6 %). The median time until androgen deprivation therapy initiation was around 15 months. The treatment was well tolerated. Neither grade 3-4 toxicity nor serious adverse events were observed. This first prospective clinical trial with MC therapy in patients with non-metastatic biochemical recurrence of PC displayed modest efficacy when measured with PSA response rate, without significant toxicity. It might offer a new safe and non-expensive option to delay initiation of ADT. These results would need to be confirmed with larger prospective randomised trials.
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http://dx.doi.org/10.1007/s12032-016-0806-0DOI Listing
August 2016

Rapalogs Efficacy Relies on the Modulation of Antitumor T-cell Immunity.

Cancer Res 2016 07 17;76(14):4100-12. Epub 2016 May 17.

INSERM UMR1098, TIMC LabEx LipSTIC, Besançon, France. University of Bourgogne Franche-Comté, UMR1098, Besançon, France. Department of Medical Oncology, University Hospital of Besançon, Besançon, France.

The rapalogs everolimus and temsirolimus that inhibit mTOR signaling are used as antiproliferative drugs in several cancers. Here we investigated the influence of rapalogs-mediated immune modulation on their antitumor efficacy. Studies in metastatic renal cell carcinoma patients showed that everolimus promoted high expansion of FoxP3 (+)Helios(+)Ki67(+) regulatory CD4 T cells (Tregs). In these patients, rapalogs strongly enhanced the suppressive functions of Tregs, mainly in a contact-dependent manner. Paradoxically, a concurrent activation of spontaneous tumor-specific Th1 immunity also occurred. Furthermore, a high rate of Eomes(+)CD8(+) T cells was detected in patients after a long-term mTOR inhibition. We found that early changes in the Tregs/antitumor Th1 balance can differentially shape the treatment efficacy. Patients presenting a shift toward decreased Tregs levels and high expansion of antitumor Th1 cells showed better clinical responses. Studies conducted in tumor-bearing mice confirmed the deleterious effect of rapalogs-induced Tregs via a mechanism involving the inhibition of antitumor T-cell immunity. Consequently, the combination of temsirolimus plus CCR4 antagonist, a receptor highly expressed on rapalogs-exposed Tregs, was more effective than monotherapy. Altogether, our results describe for the first time a dual impact of host adaptive antitumor T-cell immunity on the clinical effectiveness of rapalogs and prompt their association with immunotherapies. Cancer Res; 76(14); 4100-12. ©2016 AACR.
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http://dx.doi.org/10.1158/0008-5472.CAN-15-2452DOI Listing
July 2016

Efficacy of Adjuvant Chemotherapy in Colon Cancer With Microsatellite Instability: A Large Multicenter AGEO Study.

J Natl Cancer Inst 2016 Jul 1;108(7). Epub 2016 Feb 1.

Affiliations of authors: Department of Gastroenterology (DT, GS, CS), Department of Medical Oncology (AF), and Department of Molecular Oncology (LKT), Poitiers University Hospital , Poitiers , France ; Laboratoire Inflammation, Tissus Epithéliaux et Cytokines (LITEC) - EA 4331, Poitiers University , Poitiers (DT, CS); Methodology and Quality of Life in Oncology Unit, Besançon University Hospital , Besançon , France (GM); Department of Gastroenterology, Ambroise Paré Hospital , Boulogne-Billancourt , France (IT); Department of Gastroenterology (TL) and Department of Biochemistry (JCP), Tours University Hospital , Tours , France , UMR GICC CNRS 7292, Tours François Rabelais University, Tours (TL); Paris Descartes University, Cochin Hospital , Paris , France (RC); Department of Gastroenterology (TA) and Department of Medical Oncology (CDG), Avicenne Hospital , Bobigny , France ; Department of Gastroenterology, Bordeaux Nord Aquitaine Clinic , Bordeaux , France (CL); Department of Gastroenterology, Jean Mermoz Lyon Hospital , Lyon , France (PA); Department of Gastroenterology, Nantes University Hospital , Nantes , France (EC, TMB); Department of Gastroenterology, Rouen University Hospital , Rouen , France (DS, PM); Department of Medical Oncology, Saint-Antoine Hospital , Paris , France (TB); Department of Gastroenterology and Digestive Oncology, Georges Pompidou European Hospital, APHP , Paris , France (JT, AZ); Paris Descartes University, Sorbonne Paris Cité , Paris , France (RC, JT, AZ).

Background: Deficient mismatch repair (dMMR) colon cancer (CC) is reportedly resistant to 5-fluorouracil (5FU) adjuvant chemotherapy while preliminary data suggest chemosensitivity to oxaliplatin. We assessed the efficacy of fluoropyrimidine with and without oxaliplatin in a large cohort of dMMR CC patients.

Methods: This retrospective multicenter study included all consecutive patients who underwent curative surgical resection for stage II or III dMMR CC between 2000 and 2011. Prognostic factors were analyzed using Cox models, and hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated. All statistical tests were two-sided.

Results: A total of 433 dMMR CC patients were included (56.8% stage II, 43.2% stage III). Mean follow-up was 47.0 months. The patients received surgery alone (n = 263) or surgery plus adjuvant chemotherapy consisting of fluoropyrimidine with (n = 119) or without (n = 51) oxaliplatin. Adjuvant chemotherapy was administered to 16.7% of stage II and 69.0% of stage III CC patients. As compared with surgery alone, adjuvant oxaliplatin-based chemotherapy improved disease-free survival (DFS) in multivariable analysis (HR = 0.35, 95% CI = 0.19 to 0.65, P < .001), contrary to adjuvant fluoropyrimidine alone (HR = 0.73, 95% CI = 0.36 to 1.49, P = .38). In the subgroup analysis, the DFS benefit of oxaliplatin-based chemotherapy was statistically significant in multivariable analysis only in stage III (HR = 0.41, 95% CI = 0.19 to 0.87, P = .02).

Conclusion: This study supports the use of adjuvant chemotherapy with fluoropyrimidine plus oxaliplatin in stage III dMMR CC.
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http://dx.doi.org/10.1093/jnci/djv438DOI Listing
July 2016

Carboplatin-etoposide combination chemotherapy in metastatic castration-resistant prostate cancer: A retrospective study.

Mol Clin Oncol 2015 Nov 31;3(6):1208-1212. Epub 2015 Aug 31.

Department of Medical Oncology, University Hospital of Besançon, 25030 Besançon, France; Methodology and Quality of Life in Oncology Unit, University Hospital of Besançon, 25030 Besançon, France.

The combination of cisplatin or carboplatin and etoposide is the standard treatment for certain poorly differentiated neuroendocrine cancers, such as small-cell lung cancer. The aim of this study was to assess the efficacy and tolerability of the carboplatin-etoposide regimen in metastatic castration-resistant prostate cancer (mCRPC). A total of 27 patients treated by carboplatin [area under the curve (AUC)=5] and etoposide (100 mg/m intravenous infusion on days 1-3 or 75 mg orally/day for 10 days) for mCRPC were included for analysis. The median progression-free survival was 3.3 months [95% confidence interval (CI): 1.9-4.2] and the median overall survival (OS) was 8.1 months (95% CI: 4.06-12.36). The main grade 3-4 toxicities were haematological, namely anemia (33.3%), neutropenia (25.9%) and thrombocytopenia (22.2%), whereas the most common non-hematological toxicity was asthenia (22.2%). The efficacy, compliance and safety profile were generally similar between the oral and intravenous etoposide groups. Pretreated patients with mCRPC may benefit from the carboplatin-etoposide regimen in terms of OS. The toxicities were acceptable, without reported treatment-related mortality. Therefore, the oral etoposide regimen may be an viable alternative for improving the quality of life of the patients. However, this regimen requires further prospective investigation to confirm its efficacy.
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http://dx.doi.org/10.3892/mco.2015.628DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4665308PMC
November 2015

Sequential FOLFIRI.3 + Gemcitabine Improves Health-Related Quality of Life Deterioration-Free Survival of Patients with Metastatic Pancreatic Adenocarcinoma: A Randomized Phase II Trial.

PLoS One 2015 26;10(5):e0125350. Epub 2015 May 26.

National Quality of Life in Oncology Platform, Besançon, France; Methodological and Quality of Life in Oncology Unit (EA 3181), University Hospital of Besançon, Besançon, France.

Background: A randomized multicenter phase II trial was conducted to assess the sequential treatment strategy using FOLFIRI.3 and gemcitabine alternately (Arm 2) compared to gemcitabine alone (Arm 1) in patients with metastatic non pre-treated pancreatic adenocarcinoma. The primary endpoint was the progression-free survival (PFS) rate at 6 months. It concludes that the sequential treatment strategy appears to be feasible and effective with a PFS rate of 43.5% in Arm 2 at 6 months (26.1% in Arm 1). This paper reports the results of the longitudinal analysis of the health-related quality of life (HRQoL) as a secondary endpoint of this study.

Methods: HRQoL was evaluated using the EORTC QLQ-C30 at baseline and every two months until the end of the study or death. HRQoL deterioration-free survival (QFS) was defined as the time from randomization to a first significant deterioration as compared to the baseline score with no further significant improvement, or death. A propensity score was estimated comparing characteristics of partial and complete responders. Analyses were repeated with inverse probability weighting method using the propensity score. Multivariate Cox regression analyses were performed to identify independent factors influencing QFS.

Results: 98 patients were included between 2007 and 2011. Adjusting on the propensity score, patients of Arm 2 presented a longer QFS of Global Health Status (Hazard Ratio: 0.52 [0.31-0.85]), emotional functioning (0.35 [0.21-0.59]) and pain (0.50 [0.31-0.81]) than those of Arm 1.

Conclusion: Patients of Arm 2 presented a better HRQoL with a longer QFS than those of Arm 1. Moreover, the propensity score method allows to take into account the missing data depending on patients' characteristics.

Trial Registration Information: Eudract N° 2006-005703-34. (Name of the Trial: FIRGEM).
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0125350PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4444351PMC
February 2016

[Alternative prescription schedules of sunitinib in metastatic kidney cancer: from the underground to the light?].

Bull Cancer 2014 Sep;101(9):832-40

Oncologie médicale, Hôpital Saint-André, 33000 Bordeaux, France, Early Drug Development Certified Unit (Inserm-CIC/INCa), 33075 Bordeaux, France.

Sunitinib was the first targeted therapy improving progression-free survival (PFS) and overall survival (OS) in patients with metastatic renal cell carcinoma (mRCC) in the first line of treatment. Classically, sunitinib is administered at a dose of 50 mg/day during four weeks followed by two weeks off (schedule 4/6). This schedule has two pitfalls: intermittent exposure with two weeks "off" and the increase in toxicity during the fourth week. Several alternative prescription schedules were studied with the aim of limiting the intensity of toxicity while maintaining efficacy. This review summarizes the published data on alternative schedules of sunitinib in terms of safety and efficacy. All articles and abstracts on alternative schedule of sunitinib in the mRCC were reviewed. Clinical trials were also searched. Studies evaluating the continuous schedule have not provided evidence of its superiority compared to the 4/6 schedules in terms of activity, tolerance or dose-intensity. Retrospective data of patients treated in a schedule two weeks of treatment "on" one week "off" (schedule 2/3) with sunitinib 50 mg/day show PFS that seem superior to those obtained with a schedule 4/ 6, while having a better safety profile. The alternating schedule of sunitinib 2/3 (50 mg/day) may be a better alternative to schedule 4/6 in terms of tolerance. If toxicity occurs with 50 mg/day on a schedule 4/6, it would probably offer a better alternative in terms of efficiency than dose reduction. The results of ongoing and future studies are expected to prospectively validate the concept.
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http://dx.doi.org/10.1684/bdc.2014.2020DOI Listing
September 2014

Clinical impact of targeted therapies in patients with metastatic clear-cell renal cell carcinoma.

Onco Targets Ther 2014 27;7:365-74. Epub 2014 Feb 27.

Inserm U645 EA-2284 IFR-133, University of Franche-Comté, Besançon, France ; Department of Medical Oncology, Besançon, France.

Introduction: The aim of this retrospective clinical study was to assess, in the context of the recent evolution of systemic therapies, the potential effect of targeted therapies on overall survival (OS) of patients with metastatic clear-cell renal cell carcinoma (mccRCC) in daily practice.

Patients And Methods: All consecutive patients with histologically confirmed mccRCC who received systemic therapy between January 2000 and December 2010 in two oncology treatment centers in our Franche-Comté region in eastern France were included in the analysis. The primary end point was OS. The analysis of prognostic factors was performed using a two-step approach: univariate then multivariate analysis with a stepwise Cox proportional hazards regression model.

Results: For the entire cohort of 111 patients, the median OS was 17 months (95% confidence interval [CI]; 13-22 months) and the two-year OS was 39%. Three prognostic factors were independent predictors of long survival: prior nephrectomy (hazard ratio =0.38 [0.22-0.64], P<0.0001); systemic therapy by targeted therapy (hazard ratio =0.50 [0.31-0.80], P=0.005); and lack of liver metastasis (hazard ratio =0.43 [0.22-0.82], P=0.002). Median OS was 21 months [14-29 months] for patients who received at least one targeted therapy compared with 12 months [7-15 months] for patients who were treated only by immunotherapy agents (P=0.003).

Conclusion: Our results suggest that targeted therapies are associated with improved OS in comparison with cytokines, which is in line with other publications.
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http://dx.doi.org/10.2147/OTT.S56370DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3942215PMC
March 2014

Pathologic complete response to preoperative chemotherapy predicts cure in early-stage non-small-cell lung cancer: combined analysis of two IFCT randomized trials.

J Thorac Oncol 2012 May;7(5):841-9

Chest Disease Department, Jean Minjoz University Hospital, Besancon, France.

Introduction: Our study aimed to evaluate whether pathologic complete response (pCR) in early-stage non-small-cell lung cancer (NSCLC) after neoadjuvant chemotherapy resulted in improved outcome, and to determine predictive factors for pCR.

Methods: Eligible patients with stage-IB or -II NSCLC were included in two consecutive Intergroupe Francophone de Cancérologie Thoracique phase-III trials evaluating platinum-based neoadjuvant chemotherapy, with pCR defined by the absence of viable cancer cells in the resected surgical specimen.

Results: Among the 492 patients analyzed, 41 (8.3%) achieved pCR. In the pCR group, 5-year overall survival was 80.0% compared with 55.8% in the non-pCR group (p = 0.0007). In multivariate analyses, pCR was a favorable prognostic factor of overall survival (relative risk = 0.34; 95% confidence interval = 0.18-0.64) in addition to squamous-cell carcinoma, weight loss less than or equal to 5%, and stage-IB disease. Five-year disease-free survival was 80.1% in the pCR group compared to 44.8% in the non-pCR group (p < 0.0001). Two patients (4.9%) in the pCR group experienced disease recurrence compared to 193 patients (42.8%) in the non-pCR group. SCC subtype was the only independent predictor of pCR (odds ratio [OR] = 4.30; 95% confidence interval = 1.90-9.72).

Conclusion: Our results showed that pCR after preoperative chemotherapy was a favorable prognostic factor in stage-IB-II NSCLC. Our study is the largest published series evaluating pCRs after preoperative chemotherapy. The only factor predictive of pCR was squamous-cell carcinoma. Identifying molecular predictive markers for pCR may help in distinguishing patients likely to benefit from neoadjuvant chemotherapy and in choosing the most adequate preoperative chemotherapy regimen.
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http://dx.doi.org/10.1097/JTO.0b013e31824c7d92DOI Listing
May 2012