Publications by authors named "Rosine Guimbaud"

88 Publications

Clinical Relevance of Viable Circulating Tumor Cells in Patients with Metastatic Colorectal Cancer: The COLOSPOT Prospective Study.

Cancers (Basel) 2021 Jun 13;13(12). Epub 2021 Jun 13.

Laboratory of Rare Human Circulating Cells, University Medical Center of Montpellier, University of Montpellier, 34093 Montpellier, France.

Background: Circulating tumor cells (CTCs) allow the real-time monitoring of tumor course and treatment response. This prospective multicenter study evaluates and compares the early predictive value of CTC enumeration with EPISPOT, a functional assay that detects only viable CTCs, and with the CellSearch system in patients with metastatic colorectal cancer (mCRC).

Methods: Treatment-naive patients with mCRC and measurable disease (RECIST criteria 1.1) received FOLFIRI-bevacizumab until progression or unacceptable toxicity. CTCs in peripheral blood were enumerated at D, D, D, D, and D (EPISPOT assay) and at D and D (CellSearch system). Progression-free survival (PFS) and overall survival (OS) were assessed with the Kaplan-Meier method and log-rank test.

Results: With the EPISPOT assay, at least 1 viable CTC was detected in 21% (D), 15% (D), 12% (D), 10% (D), and 12% (D) of 155 patients. PFS and OS were shorter in patients who remained positive, with viable CTCs between D and D compared with the other patients (PFS = 7.36 vs. 9.43 months, = 0.0161 and OS = 25.99 vs. 13.83 months, = 0.0178). The prognostic and predictive values of ≥3 CTCs (CellSearch system) were confirmed.

Conclusions: CTC detection at D and the D-D CTC dynamics evaluated with the EPISPOT assay were associated with outcomes and may predict response to treatment.
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http://dx.doi.org/10.3390/cancers13122966DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8231886PMC
June 2021

Real-world safety and effectiveness of regorafenib in metastatic colorectal cancer: the French CORRELATE cohort.

Future Oncol 2021 May 20. Epub 2021 May 20.

Service d'Oncologie Médicale, CHU de Besançon, Besançon, 25000, France.

We report real-world evidence with regorafenib in previously treated metastatic colorectal cancer from the French cohort of the international, prospective, observational CORRELATE study. Patients receiving regorafenib according to French health authority approval were included. The primary end point was treatment-emergent adverse events. Overall survival and progression-free survival were secondary end points. Two hundred and forty-two patients (61% male, median age: 66 years) were enrolled. The most common grade ≥3 drug-related treatment-emergent adverse events were hand-foot skin reaction (10.3%), asthenia/fatigue (9.9/1.2%) and hypertension (6.2%). Median overall survival and progression-free survival were 6.8 (95% CI: 6.3-7.6) and 2.8 months (95% CI: 2.6-3.0), respectively. The real-world safety and effectiveness data of regorafenib in metastatic colorectal cancer in France align with findings from Phase III clinical trials and the global CORRELATE population.
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http://dx.doi.org/10.2217/fon-2021-0266DOI Listing
May 2021

The Activity of Crizotinib in Chemo-Refractory MET-Amplified Esophageal and Gastric Adenocarcinomas: Results from the AcSé-Crizotinib Program.

Target Oncol 2021 05 13;16(3):381-388. Epub 2021 Apr 13.

Gustave Roussy, Villejuif, France.

Background: The AcSé-crizotinib program provides extensive screening of crizotinib-targeted genomic alteration in several malignancies. We here report the results in patients with esogastric MET-amplified adenocarcinomas.

Objective: The objective of the study was to evaluate the efficacy and tolerability of crizotinib in patients with pretreated esogastric MET-amplified adenocarcinoma who have no alternative treatment options.

Patients And Methods: MET expression was evaluated by fluorescence in situ hybridization in tumor samples with immunohistochemistry scores ≥ 2+. Patients with chemo-refractory tumors showing ≥ 6 MET copies were eligible for crizotinib 250 mg twice daily. The primary efficacy outcome was the objective response rate after two cycles of crizotinib.

Results: MET was prospectively analyzed in 570 esogastric adenocarcinomas. Amplifications were found in 35/570 adenocarcinomas (29/523 gastric and 6/47 esophageal). Nine patients were treated with crizotinib. The objective response rate after two cycles was 33.3% (95% CI 7.5-70), the best overall response rate was 55.6% (95% CI 21.2-86.3), with median progression-free survival of 3.2 months (95% CI 1.0-5.4), and overall survival of 8.1 months (95% CI 1.7-24.6). Safety was consistent with that previously reported for crizotinib.

Conclusions: Large-scale screening for MET-amplified esogastric adenocarcinomas is feasible. MET amplification was observed in 5.5% of gastric and 12.8% of esophageal adenocarcinomas. Crizotinib shows encouraging results in selected patients. Thus, c-MET inhibition for MET-amplified tumors deserves further evaluation.

Trial Registration Number: NCT02034981.

Date Of Registration: 14 January 2014.
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http://dx.doi.org/10.1007/s11523-021-00811-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8105218PMC
May 2021

Value of a patient-reported-outcome measure of carcinoid syndrome symptoms.

Eur J Endocrinol 2021 May;184(5):711-722

Service d'Oncologie Médicale et Hépatogastroentérologie, Hospices Civil de Lyon, Lyon, France.

Objective: Literature on patient-reported outcomes (PRO) of carcinoid syndrome symptoms (CSS) is scarce. We used a patient-reported outcome measure (PROM) to evaluate CSS, the domains of daily life impacted by CSS, the main symptoms that affect daily life, its change according to clinical, biological and morphological evolution, and the risk factors for a poor PRO-CSS score.

Methods: Patients completed the PRO-CSS, EORTC-QLQ30, and GI-NET21 questionnaires at the time of their clinical, laboratory, and morphological assessments in a multicentre French cohort study from February 2019 to May 2020.

Results: In total, 147 patients with metastatic ileal (n =126), lung (n =20), or unknown primitive neuroendocrine tumour but high 5-hydroxyindole-3-acetic acid level (n =1) were included; 42 (32%) received an above-label dose of somatostatin analogues. Fifty-one (35%) patients had a poor PRO-CSS score. Travelling and food restriction were the two main domains affected. Diarrhoea (mean: 2.3/5 on Likert scale), imperiousness (mean of 2.5/5), fatigue (2.2/5), abdominal pain (1.7/5), and flushing episodes (1.5/5) were the main symptoms affecting daily life. The PRO-CSS score was not correlated to the clinical assessment performed by physicians at the baseline and during the follow-up. Patients with a poor PRO-CSS score had a higher tumour burden.

Conclusions: PROM-CSS may help physicians make an objective assessment of CSS and its impact in daily practice; this tool could become a key evaluation criterion in clinical trials focusing on CSS.
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http://dx.doi.org/10.1530/EJE-20-1138DOI Listing
May 2021

Spartalizumab in metastatic, well/poorly-differentiated neuroendocrine neoplasms.

Endocr Relat Cancer 2021 Jan 1. Epub 2021 Jan 1.

S Singh, Medical Oncologist, Sunnybrook Health Sciences Centre, Toronto, Canada.

Spartalizumab, a humanized anti-programmed death protein 1 (PD-1) monoclonal antibody, was evaluated in patients with well-differentiated metastatic grade 1/2 neuroendocrine tumors (NET) and poorly-differentiated gastroenteropancreatic neuroendocrine carcinomas (GEP-NEC). In this phase II, multicenter, single-arm study, patients received spartalizumab 400 mg every 4 weeks until confirmed disease progression or unacceptable toxicity. The primary endpoint was confirmed overall response rate (ORR) according to blinded independent review committee using response evaluation criteria in solid tumors 1.1. The study enrolled 95 patients in the NET group (30, 32 and 33 in the thoracic, gastrointestinal, and pancreatic cohorts, respectively), and 21 patients in the GEP-NEC group. The ORR was 7.4% (95% confidence interval [CI]: 3.0, 14.6) in the NET group (thoracic, 16.7%; gastrointestinal, 3.1%; pancreatic, 3.0%), which was below the predefined success criterion of ≥10%, and 4.8% (95% CI: 0.1, 23.8) in the GEP-NEC group. In the NET and GEP-NEC groups, the 12-month progression-free survival was 19.5% and 0%, respectively, and the 12-month overall survival was 73.5% and 19.1%, respectively. The ORR was higher in patients with ≥1% PD-L1 expression in immune/tumor cells or ≥1% CD8+ cells at baseline. The most common adverse events considered as spartalizumab-related included fatigue (29.5%) and nausea (10.5%) in the NET group, and increased aspartate and alanine aminotransferases (each 14.3%) in the GEP-NEC group. The efficacy of spartalizumab was limited in this heterogeneous and heavily pre-treated population; however, the results in the thoracic cohort is encouraging and warrants further investigation. Adverse events were manageable and consistent with previous experience.
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http://dx.doi.org/10.1530/ERC-20-0382DOI Listing
January 2021

PRODIGE 59-DURIGAST trial: A randomised phase II study evaluating FOLFIRI + Durvalumab ± Tremelimumab in second-line of patients with advanced gastric cancer.

Dig Liver Dis 2021 Apr 6;53(4):420-426. Epub 2021 Jan 6.

Service d'Oncologie Médicale, CHU de Poitiers, Poitiers, France; Service d'Hépato-gastroentérologie, CHU de Poitiers et Université de Poitiers, 2 rue de la Milétrie, Poitiers 86021, France. Electronic address:

Gastric or gastro-oesophageal junction (GEJ) adenocarcinomas present poor overall survival (OS). First-line chemotherapy regimen for patients with HER2-negative tumours is based on a doublet or triplet of fluoropyrimidine plus platinum salt ± taxane. Second-line chemotherapy (Docetaxel or Irinotecan) improves OS which nonetheless remains poor (around 5 months). The first results of immune checkpoint inhibitors (anti-PD-1) combined with chemotherapy in metastatic gastric and GEJ cancers were discordant in recent phase III trials. Data on dual-blockade (anti-PD-L1 or anti-PD-1 plus anti-CTLA-4) plus chemotherapy are lacking. DURIGAST is a randomised, multicenter, non-comparative, phase II study, evaluating safety and efficacy of FOLFIRI plus Durvalumab (anti-PD-L1) versus FOLFIRI plus Durvalumab and Tremelimumab (anti-CTLA-4) as second-line treatment of advanced gastric and GEJ adenocarcinoma. The primary objective is the rate of patients alive and without progression at 4 months. The main inclusion criteria are: patients with advanced gastric or GEJ adenocarcinoma, pre-treated with fluoropyrimidine + platinum salt ± taxane. Due to a lack of data on FOLFIRI, Durvalumab and Tremelimumab combination, a 2-step safety run-in phase has been performed before the randomised phase II. The safety run-in phase did not show any safety issue and the randomised phase II starts in September 2020.
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http://dx.doi.org/10.1016/j.dld.2020.11.036DOI Listing
April 2021

Sorafenib Plus Irinotecan Combination in Patients With RAS-mutated Metastatic Colorectal Cancer Refractory To Standard Combined Chemotherapies: A Multicenter, Randomized Phase 2 Trial (NEXIRI-2/PRODIGE 27).

Clin Colorectal Cancer 2020 12 15;19(4):301-310.e1. Epub 2020 May 15.

Medical Oncology Departement, Institut du Cancer de Montpellier (ICM), Univ. Montpellier, Montpellier, France; Institut régional du Cancer de Montpellier (IRCM), INSERM, Univ. Montpellier, ICM, Montpellier.

Background: No treatment option was available for patients with RAS-mutated (RASmt) metastatic colorectal cancer (mCRC) who progress after standard combined chemotherapies at the time of the study. After promising results in phase II, the aim of the present NEXIRI-2/PRODIGE 27 trial was to assess the 2-month non-progression rate for sorafenib (NEX) plus irinotecan (IRI), that is, NEXIRI, treatment.

Methods: Patients with RASmt mCRC after failure of oxaliplatin, IRI, fluoropyrimidines, and bevacizumab were randomized between NEXIRI (IRI 120-180 mg/m intravenous, D1 = D15 plus oral NEX 400 mg twice a day) versus IRI (180 mg/m) versus NEX. Primary endpoint was the 2-month non-progression rate. Secondary endpoints included progression-free and overall survival (PFS and OS), safety, and germline cyclin D1 (CCND1) rs9344 polymorphisms analyses.

Results: A total of 173 patients were included, 59 in NEXIRI, 57 in IRI, and 57 in NEX arms. The 2-month non-progression rate was 52.6% (95% confidence interval [CI]: 39%-66%), 21.4% (10%-33%), and 19.3% (9%-30%) for NEXIRI, IRI, and NEX. Median PFS was 3.6 (95% CI: 2-4.2), 1.7 (1.7-1.8), and 2 (1.8-2.3) months and the median OS was 7.2 (5.8-9.4), 6.3 (4.8-8), and 5.6 (3.9-7.7) months for NEXIRI, IRI, and NEX, respectively. For NEXIRI rs9344CCND1 A/A genotype patients, OS was 19.6 months (95% CI: 4.8-not reached). Main grade 3 toxicities included neutropenia, febrile neutropenia, diarrhea, hand-foot syndrome, and hypertension.

Conclusions: In patients with RASmt mCRC who progressed after standard combined chemotherapies, the results of 2-month non-progression rate and median PFS in the NEXIRI arm were in favor of an increase of the time before progression.
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http://dx.doi.org/10.1016/j.clcc.2020.04.008DOI Listing
December 2020

Successful and Safe Treatment With 177Lu-DOTATATE (Lutathera) of Progressive Metastatic Pancreatic Neuroendocrine Tumor Under Hemodialysis.

Clin Nucl Med 2020 Sep;45(9):e400-e402

Department of Digestive Oncology, Centre Hospitalo-Universitaire (CHU) de Toulouse, Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, France.

Lu-DOTATATE is an effective treatment for inoperable metastatic well-differentiated pancreatic neuroendocrine tumors. There are no guidelines for patients with terminal renal failure. We present the case of a 74-year-old woman who received different lines of treatment: analogs of somatostatin, chemotherapy, a first series of peptide receptor radionuclide therapy (PRRT), and finally chemoembolization. Because of persistent hepatic progression, a safe and successful administration of 4 cycles of a second series of PRRT under hemodialysis was administered. Patient was in scintigraphic complete remission at 12 months with normal hematological parameters at 12 and 30 months after PRRT.
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http://dx.doi.org/10.1097/RLU.0000000000003202DOI Listing
September 2020

Intra-arterial hepatic beads loaded with irinotecan (DEBIRI) with mFOLFOX6 in unresectable liver metastases from colorectal cancer: a Phase 2 study.

Br J Cancer 2020 08 8;123(4):518-524. Epub 2020 Jun 8.

Département de Gastroentérologie et d'Oncologie Digestive, Hôpital Européen George Pompidou, Paris, France.

Background: Chemo-embolisation with drug-eluting beads loaded with irinotecan (DEBIRI) increased survival as compared with intravenous irinotecan in chemorefractory patients with liver-dominant metastases from colorectal cancer (LMCRC). First-line DEBIRI with systemic chemotherapy may increase survival and secondary resection.

Methods: In the FFCD-1201 single-arm Phase 2 study, patients with untreated, non-resectable LMCRC received DEBIRI plus mFOLFOX6. Four courses of DEBIRI were performed alternating right and left lobe or two sessions with both lobes treated during the same session.

Results: Fifty-seven patients were enrolled. Grade 3-5 toxicities were more frequent when both lobes were treated during the same session (90.5% versus 52.8%). Nine-month PFS rate was 53.6% (95% CI, 41.8-65.1%). The objective response rate (RECIST 1.1) was 73.2%, and the secondary R0 surgery was 33%. With a median follow-up of 38.3 months, median OS was 37.4 months (95% CI, 25.7-45.8), and median PFS 10.8 months (95% CI, 8.2-12.3).

Conclusions: Front-line DEBIRI + mFOLFOX6 should not be recommended as the hypothesised 9-month PFS was not met. However, high response rate, deep responses, and prolonged OS encourage further evaluation in strategies integrating biologic agent, in particular in patients with secondary surgery as the main goal.

Clinical Trial Registration: NCT01839877.
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http://dx.doi.org/10.1038/s41416-020-0917-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7435188PMC
August 2020

[COVID-19 impact on the cancer care structuration: Example of the multidisciplinary team meeting dedicated to oncology in Occitanie].

Bull Cancer 2020 Jul - Aug;107(7-8):730-737. Epub 2020 May 18.

UMR 1027, université de Toulouse Paul Sabatier, Inserm, 31000 Toulouse, France; Réseau régional d'Onco-Occitanie, IUCT-Oncopole, 1, avenue Irène-Joliot-Curie, 31100 Toulouse, France.

This work examines the impact of the SARS-CoV2 epidemic and the organizational recommendations that have been issued since March 16 on tumor boards (TB) activity. The tumor board activity was measured from tumor board sheets extracted from the oncologic electronic file between January 7, 2019 and April 24, 2020. The pre-containment activity was compared to the activity of the containment periods but also to the equivalent periods in 2019. The number of meetings held, the average number of files reviewed per meeting including first presentations and the average number of physicians' attendance were the evaluation criteria. The study covered 191 TB that held 3943 multidisciplinary team meetings (MTM) and reviewed 72,070 files (including 30,127 first submissions). There was a moderate decrease of 8 % in the number of meetings after March 16, 2020. The number of files examined decreased by 23 % in the following month and even more by 33 % in the third period. The physicians' number who attended MTM also decreased by 25 %. The negative impact was higher in the Mediterranean part of the region. This first study of tumor board activity, covering a large region but little affected by the pandemic, shows that its impact on the participation to the MTM has been moderate. In addition, tumor boards have followed the recommendations for optimizing quorum. However, the decrease in average MTM activity, particularly for first submissions, suggests a potential delay in patient management. Complementary qualitative and quantitative works are warranted to estimate the real impact on carcinologic outcomes.
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http://dx.doi.org/10.1016/j.bulcan.2020.05.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7231733PMC
August 2020

Genetic, structural, and functional characterization of POLE polymerase proofreading variants allows cancer risk prediction.

Genet Med 2020 09 19;22(9):1533-1541. Epub 2020 May 19.

Service de Génétique et Biologie Moléculaires, Hôpital Cochin, APHP Centre Université de Paris and Inserm UMR_S1016, Institut Cochin, Université de Paris, Paris, France.

Purpose: Polymerase proofreading-associated polyposis is a dominantly inherited colorectal cancer syndrome caused by exonuclease domain missense variants in the DNA polymerases POLE and POLD1. Manifestations may also include malignancies at extracolonic sites. Cancer risks in this syndrome are not yet accurately quantified.

Methods: We sequenced POLE and POLD1 exonuclease domains in 354 individuals with early/familial colorectal cancer (CRC) or adenomatous polyposis. We assessed the pathogenicity of POLE variants with yeast fluctuation assays and structural modeling. We estimated the penetrance function for each cancer site in variant carriers with a previously published nonparametric method based on survival analysis approach, able to manage unknown genotypes.

Results: Pathogenic POLE exonuclease domain variants P286L, M294R, P324L, N363K, D368N, L424V, K425R, and P436S were found in ten families. The estimated cumulative risk of CRC at 30, 50, and 70 years was 11.1% (95% confidence interval [CI]: 4.2-17.5), 48.5% (33.2-60.3), and 74% (51.6-86.1). Cumulative risk of glioblastoma was 18.7% (3.2-25.8) at 70 years. Variants interfering with DNA binding (P286L and N363K) had a significantly higher mutagenic effect than variants disrupting ion metal coordination at the exonuclease site.

Conclusion: The risk estimates derived from this study provide a rational basis on which to provide genetic counseling to POLE variant carriers.
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http://dx.doi.org/10.1038/s41436-020-0828-zDOI Listing
September 2020

Hydroxychloroquine in Coronavirus Disease 2019 Patients: What Still Needs to Be Known About the Kinetics.

Clin Infect Dis 2020 12;71(11):2962-2964

UMR INTHERES, INRA-ENVT, Toulouse, France.

Different dosage regimens of hydroxychloroquine are used to manage coronavirus disease 2019 (COVID-19) patients, without information on the pharmacokinetics in this population. Blood samples (n = 101) were collected from 57 COVID-19 patients for 7 days, and concentrations were compared with simulated kinetic profiles. Hydroxychloroquine exposure is low and cannot be predicted by other populations.
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http://dx.doi.org/10.1093/cid/ciaa558DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7239205PMC
December 2020

How does comorbidity affect colon cancer patients' care trajectory? Results from the French EvaCCoR cohort study.

Clin Res Hepatol Gastroenterol 2021 Jan 16;45(1):101422. Epub 2020 Apr 16.

UMR 1027 Inserm-University Toulouse 3 Paul Sabatier, Équipe labélisée LIGUE contre le cancer, Toulouse, France. Electronic address:

Objective: Due to their advanced age in average, colon cancer patients are likely to be exposed to comorbidity. However, the influence of comorbidity on patients' care trajectory and survival is largely under-explored. Hence, we investigate the effect of comorbidity on patients care trajectory and survival based on an observational study in "real-life" setting.

Methods: This prospective observational study in two French regions includes patients aged over 18 and firstly treated for a colon cancer, stage II and III, diagnosed between 1st January and 31st December 2010. We assessed the influence of comorbidity (severe vs moderate or none), using the Charlson Comorbidity Index, on overall survival and patients' management steps.

Results: We analyzed 762 patients. We found comorbidity to be associated with adjuvant treatment delivery with a longer delay between surgery and chemotherapy initiation among patients with severe comorbidity. Severe comorbidity had an independent detrimental effect on overall survival that is slightly downsized after adjustment for adjuvant treatment delivery.

Conclusion: Using observational "real-life" data, we showed that comorbidity impacts the colon cancer patients' care trajectory directly but also through indirect pathways involving adjuvant chemotherapy delivery. However, further studies are needed to better understand this mechanism.
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http://dx.doi.org/10.1016/j.clinre.2020.03.022DOI Listing
January 2021

[Localized MSI/dMMR gastric cancer patients, perioperative immunotherapy instead of chemotherapy: The GERCOR NEONIPIGA phase II study is opened to recruitment].

Bull Cancer 2020 Apr 10;107(4):438-446. Epub 2020 Feb 10.

AP-HP, Sorbonne Université, hôpital Saint-Antoine, department of medical oncology, 75012 Paris, France.

Introduction: Perioperative chemotherapy is the standard strategy for localized gastric cancers. Nevertheless, this strategy seems to be inefficient, if not deleterious, for patients with tumors harboring microsatellite instability (MSI) and/or mismatch repair deficiency (dMMR), a tumor phenotype predictive for the efficacy of immune checkpoint inhibitors (ICKi).

Aim: The GERCOR NEONIPIGA single-arm phase II study (NCT04006262; EUDRACT 2018-004712-22) aims at evaluating the efficacy of a peri-operative strategy with nivolumab and ipilimumab in neoadjuvant setting, then nivolumab alone after surgery for patients with resectable MSI/dMMR gastric cancer.

Material And Methods: Main inclusion criteria are: gastric and oesogastric junction adenocarcinoma (GOA), T2-T4, all N stage and M0, MSI/dMMR. Patients will be treated with nivolumab 240mg Q2W, 6 infusions, and ipilimumab 1mg/kg Q6W, 2 infusions in neoadjuvant setting. Following surgery, patients with TRG 1-2-3 (Mandard tumor regression grade), acceptable tolerance of neoadjuvant treatment and postoperative ECOG performance status 0-1, will be treated with adjuvant nivolumab 480mg Q4W, 9 infusions.

Results: The primary endpoint is pathological complete response rate (pCR-R). Based on a Fleming design, with α=5% and β=20%, 27 patients have to be evaluated (H0=5%; H1=20%). Secondary endpoints include disease-free survival, overall survival and safety.

Conclusion: This study is planned to include 32 patients to evaluate the pCR-R with the combination of nivolumab and ipilimumab in neoadjuvant setting for MSI/dMMR localized GOA. The MSI/MMR status should be systematically assessed on diagnostic biopsies of all GOA. If it meets its primary endpoint, the GERCOR NEONIPIGA study might mark a turning point in the management of localized MSI/dMMR GOA patients.
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http://dx.doi.org/10.1016/j.bulcan.2019.11.016DOI Listing
April 2020

Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy in second-line treatment of advanced pancreatic cancer: An open-label, randomized Phase IIb trial.

Eur J Cancer 2020 01 21;124:91-101. Epub 2019 Nov 21.

ERYTECH, One Main Street, Suite 1150, Cambridge, MA 02142, USA.

Purpose: This Phase IIb (NCT02195180) open-label study evaluated erythrocyte-encapsulated asparaginase (eryaspase) in combination with chemotherapy in second-line advanced pancreatic adenocarcinoma.

Methods: Eligible patients were randomized 2:1 to either eryaspase in combination with gemcitabine or mFOLFOX6 (eryaspase arm), or to gemcitabine or mFOLFOX6 alone (control arm). Co-primary endpoints were overall survival (OS) and progression-free survival (PFS) in patients with low asparagine synthetase (ASNS) expression. Secondary endpoints included OS and PFS in the entire population.

Results: 141 patients were randomized (eryaspase arm, n = 95; control arm, n = 46). Median OS and PFS in patients with low ASNS expression were 6.2 months (95% CI, 5.1-8.8) in the eryaspase arm versus 4.9 months (3.1-7.1) in the control arm (HR, 0.63; 95% CI, 0.39-1.01; P = 0.056) and 2.0 months (95% CI, 1.8-3.4) in the eryaspase arm versus 1.8 months (1.4-3.8) in the control arm (HR, 0.67; 95% CI, 0.40-1.12; P = 0.127), respectively. In the entire population, median OS and PFS for the eryaspase arm versus control were 6.0 months versus 4.4 months (HR, 0.60; P = 0.008) and 2.0 months versus 1.6 months (HR, 0.56; 95% CI, 0.37-0.84; P = 0.005), respectively. The combination of eryaspase and chemotherapy was well tolerated. The most frequent Grade 3/4 adverse events in the eryaspase arm (n = 93) were gamma-glutamyltransferase increase (16 [17.2%]), neutropenia (12 [12.9%]), and physical health deterioration (12 [12.9%]).

Conclusion: Eryaspase in combination with chemotherapy is associated with improvements in OS and PFS, irrespective of ASNS expression in second-line advanced pancreatic adenocarcinoma. A Phase III trial is underway.
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http://dx.doi.org/10.1016/j.ejca.2019.10.020DOI Listing
January 2020

Phase II Open-Label Study of Pembrolizumab in Treatment-Refractory, Microsatellite Instability-High/Mismatch Repair-Deficient Metastatic Colorectal Cancer: KEYNOTE-164.

J Clin Oncol 2020 01 14;38(1):11-19. Epub 2019 Nov 14.

Sorbonne Université, Paris, France.

Purpose: KEYNOTE-164 (NCT02460198) evaluated the antitumor activity of pembrolizumab in previously treated, metastatic, microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) colorectal cancer (CRC).

Methods: This phase II open-label study involved 128 centers worldwide. Eligible patients were age ≥ 18 years and had metastatic MSI-H/dMMR CRC treated with ≥ 2 prior lines of standard therapy, including fluoropyrimidine, oxaliplatin, and irinotecan with or without anti-vascular endothelial growth factor/epidermal growth factor receptor monoclonal antibody (cohort A) or ≥ 1 prior line of therapy (cohort B). MSI-H/dMMR status was assessed locally. Patients received pembrolizumab 200 mg every 3 weeks for up to 2 years until progression, unacceptable toxicity, or withdrawal. The primary end point was objective response rate by RECIST version 1.1 by independent central review. Secondary end points were duration of response, progression-free survival (PFS), overall survival, safety, and tolerability.

Results: A total of 124 patients with MSI-H/dMMR CRC (61 in cohort A, 63 in cohort B) enrolled. At data cutoff, median follow-up was 31.3 months (range, 0.2-35.6 months) for cohort A and 24.2 months (range, 0.1-27.1 months) for cohort B. Objective response rate was 33% (95% CI, 21% to 46%) and 33% (95% CI, 22% to 46%), respectively, with median duration of response not reached in either cohort. Median PFS was 2.3 months (95% CI, 2.1 to 8.1 months) and 4.1 months (95% CI, 2.1 to 18.9 months). Median overall survival was 31.4 months (95% CI, 21.4 months to not reached) and not reached (95% CI, 19.2 months to not reached). Treatment-related grade 3-4 adverse events occurred in 10 patients (16%) in cohort A and 8 (13%) in cohort B, with the most common occurring in ≥ 2 patients being pancreatitis, fatigue, increased alanine aminotransferase, and increased lipase (2 patients each; 3%) in cohort A.

Conclusion: Pembrolizumab is effective with a manageable safety profile in patients with MSI-H/dMMR CRC.
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http://dx.doi.org/10.1200/JCO.19.02107DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7031958PMC
January 2020

Everolimus after hepatic arterial embolisation therapy of metastases from gastrointestinal neuroendocrine tumours: The FFCD 1104-EVACEL-GTE phase II study.

Eur J Cancer 2019 12 31;123:92-100. Epub 2019 Oct 31.

Interventional Radiology Department, Gustave Roussy Villejuif & UFR Medecine Kremlin Bicetre Paris Sud University, Villejuif, France.

Background: Hepatic arterial embolisation therapy (HAET) is a treatment of liver metastases of gastrointestinal neuroendocrine tumours (GI-NETs). HAET increases circulating vascular endothelial growth factor levels. Everolimus is a treatment in NETs that may have antiangiogenic activity.

Methods: This phase II study was conducted in patients with predominant and progressive liver metastases from GI-NETs. Everolimus was initiated 7-30 days after HAET. The hypothesis was that everolimus after HAET would increase hepatic progression-free survival (hPFS) rate at 24 months from 35% to 50%.

Results: Among the 74 patients included, 88% had small-bowel primary tumour, 43% had grade I and 57% grade II tumour, and 51% had extrahepatic metastases. Patients underwent one (n = 19), two (n = 54), or three (n = 1) HAET procedures. hPFS at 24 months was 33% (95% confidence interval [CI], 22.5-43.7); 40 (54%) patients had objective response. Median (95% CI) hPFS, PFS, and overall survival were 19 (14-23), 17 (13-22), and 51 (33-60) months. The most common grade III-IV toxicities (>5%) in patients receiving both HAET and everolimus (n = 67) were elevated liver enzymes (55%), fatigue (18%), diarrhoea (16%), anaemia (12%), hypertriglyceridaemia (7%) and mucositis (6%).

Conclusions: The primary end-point was not reached. This sequence allows high liver response with HAET, and everolimus controls the extrahepatic disease.

Trial Registration: NCT01678664 (clinicaltrials.gov).
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http://dx.doi.org/10.1016/j.ejca.2019.09.021DOI Listing
December 2019

Medulloblastomas associated with an APC germline pathogenic variant share the good prognosis of CTNNB1-mutated medulloblastomas.

Neuro Oncol 2020 01;22(1):128-138

Curie Institute, SIREDO Cancer Center (Care, Innovation and Research in Pediatric, Adolescents, and Young Adults Oncology), Paris, France.

Background: Medulloblastomas may occur in a predisposition context, including familial adenomatosis polyposis. Medulloblastomas related to a germline pathogenic variant of adenomatous polyposis coli (APC) remain rare and poorly described. Their similarities with sporadic WNT medulloblastomas still require description.

Methods: We performed a multicentric retrospective review of 12 patients treated between 1988 and 2018 for medulloblastoma with an identified or highly suspected (personal or familial history) APC germline pathogenic variant. We report personal and familial history APC gene pathogenic variants whenever available: clinical and histologic characteristics of the medulloblastoma, treatments, and long-term outcome, including second tumor and late sequelae.

Results: Medulloblastomas associated with APC pathogenic variants are mainly classic (11/11 patients, 1 not available), nonmetastatic (10/12 patients) medulloblastomas, with nuclear immunoreactivity for ß-catenin (9/9 tested cases). Ten of 11 assessable patients are disease free with a median follow-up of 10.7 years (range, 1-28 y). Secondary tumors included desmoid tumors in 7 patients (9 tumors), 1 thyroid carcinoma, 2 pilomatricomas, 1 osteoma, 1 vertebral hemangioma, and 1 malignant triton in the radiation field, which caused the only cancer-related death in our series.

Conclusions: Medulloblastomas associated with an APC pathogenic variant have an overall favorable outcome, even for metastatic tumors. Yet, long-term survival is clouded by second tumor occurrence; treatment may play some role in some of these second malignancies. Our findings raise the question of applying a de-escalation therapeutic protocol to treat patients with APC germline pathogenic variants given the excellent outcome, and reduced intensity of craniospinal irradiation may be further evaluated.
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http://dx.doi.org/10.1093/neuonc/noz154DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6954432PMC
January 2020

Characteristics of Mutant, Deficient Mismatch Repair/Proficient Mismatch Repair, Metastatic Colorectal Cancer: A Multicenter Series of 287 Patients.

Oncologist 2019 12 31;24(12):e1331-e1340. Epub 2019 May 31.

Department of Gastroenterology, Poitiers University Hospital, Poitiers, France.

Background: mutations occurring in about 10% of metastatic colorectal cancers (mCRCs) are usually associated with a poor outcome. However, their prognostic factors are unknown.

Materials And Methods: We built a multicenter clinico-biological database gathering data from patients with -mutant mCRC treated in one of the 16 French centers from 2006 to 2017. The primary endpoint was to identify prognostic factors using a Cox model.

Results: We included 287 patients (median age, 67 years [28-95]; female, 57%). Their median overall survival was 20.8 months (95% confidence interval [CI], 17.97-27.04), and median progression-free survival in the first-line setting was 4.34 months (95% CI, 3.81-5.03). Chemotherapy regimen and biological agents (antiangiogenic or anti-epidermal growth factor receptor) were not associated with overall and progression-free survival. Stage IV disease (synchronous metastases) and absence of curative-intent surgery were statistically associated with poor overall survival. Among the 194 patients with mismatch repair (MMR) status available, overall survival was significantly longer in patients with deficient MMR tumors compared with those with proficient MMR tumors (adjusted hazard ratio = 0.56; = .009).

Conclusion: Despite that -mutant mCRCs are associated with poor overall and progression-free-survival, patients with deficient MMR tumors and/or resectable disease experienced a longer survival. These results highlight the importance of MMR testing and resectability discussion in patients with mCRC in day-to-day practice.

Implications For Practice: Mismatch repair (MMR) testing and resectability discussion in patients with metastatic colorectal cancer (mCRC) should be performed in day-to-day practice to steer treatment decision making in patients with -mutant mCRC.
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http://dx.doi.org/10.1634/theoncologist.2018-0914DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6975964PMC
December 2019

Circulating Tumor Cells and Circulating Tumor DNA Detection in Potentially Resectable Metastatic Colorectal Cancer: A Prospective Ancillary Study to the Unicancer Prodige-14 Trial.

Cells 2019 05 28;8(6). Epub 2019 May 28.

Department of Surgical Oncology, Institut Curie, PSL Research University, 75005 Paris, France.

The management of patients with colorectal cancer (CRC) and potentially resectable liver metastases (LM) requires quick assessment of mutational status and of response to pre-operative systemic therapy. In a prospective phase II trial (NCT01442935), we investigated the clinical validity of circulating tumor cell (CTC) and circulating tumor DNA (ctDNA) detection. CRC patients with potentially resectable LM were treated with first-line triplet or doublet chemotherapy combined with targeted therapy. CTC (Cellsearch) and Kirsten RAt Sarcoma (KRAS) ctDNA (droplet digital polymerase chain reaction (PCR)) levels were assessed at inclusion, after 4 weeks of therapy and before LM surgery. 153 patients were enrolled. The proportion of patients with high CTC counts (≥3 CTC/7.5mL) decreased during therapy: 19% (25/132) at baseline, 3% (3/108) at week 4 and 0/57 before surgery. ctDNA detection sensitivity at baseline was 91% (N=42/46) and also decreased during treatment. Interestingly, persistently detectable KRAS ctDNA (p=0.01) at 4 weeks was associated with a lower R0/R1 LM resection rate. Among patients who had a R0/R1 LM resection, those with detectable ctDNA levels before liver surgery had a shorter overall survival (p<0.001). In CRC patients with limited metastatic spread, ctDNA could be used as liquid biopsy tool. Therefore, ctDNA detection could help to select patients eligible for LM resection.
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http://dx.doi.org/10.3390/cells8060516DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6627974PMC
May 2019

Predictive factors of histological response of colorectal liver metastases after neoadjuvant chemotherapy.

World J Gastrointest Oncol 2019 Apr;11(4):295-309

Department of Digestive Surgery and Liver Transplantation, Toulouse-Rangueil University Hospital, Toulouse 31059, France.

Background: Colorectal cancer is the third most common cancer in men and the second most common in women worldwide. Almost a third of the patients has or will develop liver metastases. Neoadjuvant chemotherapy (NAC) has recently become nearly systematic prior to surgery of colorectal livers metastases (CRLMs). The response to NAC is evaluated by radiological imaging according to morphological criteria. More recently, the response to NAC has been evaluated based on histological criteria of the resected specimen. The most often used score is the tumor regression grade (TRG), which considers the necrosis, fibrosis, and number of viable tumor cells.

Aim: To analyze the predictive factors of the histological response, according to the TRG, on CRLM surgery performed after NAC.

Methods: From January 2006 to December 2013, 150 patients who had underwent surgery for CRLMs after NAC were included. The patients were separated into two groups based on their histological response, according to Rubbia-Brandt TRG. Based on their TRG, each patient was either assigned to the responder (R) group (TRG 1, 2, and 3) or to the non-responder (NR) group (TRG 4 and 5). All of the histology slides were re-evaluated in a blind manner by the same specialized pathologist. Univariate and multivariate analyses were performed.

Results: Seventy-four patients were classified as responders and 76 as non-responders. The postoperative mortality rate was 0.7%, with a complication rate of 38%. Multivariate analysis identified five predictive factors of histological response. Three were predictive of non-response: More than seven NAC sessions, the absence of a radiological response after NAC, and a repeat hepatectomy ( < 0.005). Two were predictive of a good response: A rectal origin of the primary tumor and a liver-first strategy ( < 0.005). The overall survival was 57% at 3 yr and 36% at 5 yr. The disease-free survival rates were 14% at 3 yr and 11% at 5 yr. The factors contributing to a poor prognosis for disease-free survival were: No histological response after NAC, largest metastasis > 3 cm, more than three preoperative metastases, R1 resection, and the use of a targeted therapy with NAC ( < 0.005).

Conclusion: A non-radiological response and a number of NAC sessions > 7 are the two most pertinent predictive factors of non-histological response (TRG 4 or 5).
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http://dx.doi.org/10.4251/wjgo.v11.i4.295DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6475675PMC
April 2019

[Adapting the care pathway].

Soins Gerontol 2019 Jan - Feb;24(135):15-18

Centre de coordination en cancérologie, Hôpital Purpan, CHU de Toulouse, place du Docteur-Baylac, 31059 Toulouse, France.

The implementation of cross-functional measures along the care pathway of cancer patients in France is globally lower in the elderly. However, age is not a criterion for excluding curative treatment, and the evaluation of physical, psychological and social resources and comorbidities is particularly significant in this population. Identifying needs in terms of support care which influences the patient's quality of life as well as the efficacy of treatments is also essential. The objective of geriatric oncology coordination is to offer elderly cancer patients global treatment, curative or otherwise, through the putting in place of a personalised care programme.
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http://dx.doi.org/10.1016/j.sger.2018.11.004DOI Listing
May 2019

SOURCE: A Registry-Based Prediction Model for Overall Survival in Patients with Metastatic Oesophageal or Gastric Cancer.

Cancers (Basel) 2019 Feb 5;11(2). Epub 2019 Feb 5.

Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.

Prediction models are only sparsely available for metastatic oesophagogastric cancer. Because treatment in this setting is often preference-based, decision-making with the aid of a prediction model is wanted. The aim of this study is to construct a prediction model, called SOURCE, for the overall survival in patients with metastatic oesophagogastric cancer. Data from patients with metastatic oesophageal ( = 8010) or gastric ( = 4763) cancer diagnosed during 2005⁻2015 were retrieved from the nationwide Netherlands cancer registry. A multivariate Cox regression model was created to predict overall survival for various treatments. Predictor selection was performed via the Akaike Information Criterion and a Delphi consensus among experts in palliative oesophagogastric cancer. Validation was performed according to a temporal internal-external scheme. The predictive quality was assessed with the concordance-index (c-index) and calibration. The model c-indices showed consistent discriminative ability during validation: 0.71 for oesophageal cancer and 0.68 for gastric cancer. The calibration showed an average slope of 1.0 and intercept of 0.0 for both tumour locations, indicating a close agreement between predicted and observed survival. With a fair c-index and good calibration, SOURCE provides a solid foundation for further investigation in clinical practice to determine its added value in shared decision making.
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http://dx.doi.org/10.3390/cancers11020187DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6406639PMC
February 2019

Correction: Protein biomarkers predictive for response to anti-EGFR treatment in RAS wild-type metastatic colorectal carcinoma.

Br J Cancer 2018 Aug;119(3):387

Department of Translational Research, Institut Curie, PSL Research University, 26 rue d'Ulm, Paris, 75005, France.

Supplementary Table 1 and the Supplementary Figure legends were not included when this manuscript was first published. The files are now available here.
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http://dx.doi.org/10.1038/s41416-018-0130-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6079395PMC
August 2018

Diversity of genetic events associated with MLH1 promoter methylation in Lynch syndrome families with heritable constitutional epimutation.

Genet Med 2018 12 12;20(12):1589-1599. Epub 2018 Apr 12.

Inserm UMR-S 1172, JPA Research Center, Lille University, and Department of Biochemistry and Molecular Biology, Lille University Hospital, Lille, France.

Purpose: Constitutional epimutations are an alternative to genetic mutations in the etiology of genetic diseases. Some of these epimutations, termed secondary, correspond to the epigenetic effects of cis-acting genetic defects transmitted to the offspring following a Mendelian inheritance pattern. In Lynch syndrome, a few families with such apparently heritable MLH1 epimutations have been reported so far.

Methods: We designed a long-range polymerase chain reaction next-generation sequencing strategy to screen MLH1 entire gene and applied it to 4 French families with heritable epimutations and 10 additional patients with no proven transmission of their epimutations.

Results: This strategy successfully detected the insertion of an Alu element in MLH1 coding sequence in one family. Two previously unreported MLH1 variants were also identified in other epimutation carriers: a nucleotide substitution within intron 1 and a single-nucleotide deletion in the 5'-UTR. Detection of a partial MLH1 duplication in another family required multiplex ligation-dependent probe amplification technology. We demonstrated the segregation of these variants with MLH1 methylation and studied the functional consequences of these defects on transcription.

Conclusion: This is the largest cohort of patients with MLH1 secondary epimutations associated with a broad spectrum of genetic defects. This study provides further insight into the complexity of molecular mechanisms leading to secondary epimutations.
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http://dx.doi.org/10.1038/gim.2018.47DOI Listing
December 2018

Current Management and Predictive Factors of Lymph Node Metastasis of Appendix Neuroendocrine Tumors: A National Study from the French Group of Endocrine Tumors (GTE).

Ann Surg 2019 07;270(1):165-171

Hospices Civils de Lyon, Hôpital Edouard Herriot, Service de Gastroentérologie et d'Oncologie Médicale, Lyon, France.

Objective: The primary endpoint was to analyze the predictive factors of lymph node involvement (LN+).

Background: Indications for additional right hemicolectomy (RHC) with lymph node (LN) resection after appendectomy for appendix neuroendocrine tumor (A-NET) remain controversial, especially for tumors between 1 and 2 cm in size.

Methods: National study including all patients with nonmetastatic A-NET diagnosed after January, 2010 in France.

Results: In all, 403 patients were included. A-NETs were: within tip (67%), body (24%) or base (9%) of the appendix; tumor size was < 1 cm (62%), 1 to 2 cm (30%), or >2 cm (8%); grade 1 (91%); mesoappendix involvement 3 mm (5%); lymphovascular (15%) or perineural (24%) invasion; and positive resection margin (8%). According to the European NeuroEndocrine Tumor Society (ENETS) recommendations, 85 patients (21%) should have undergone RHC. The agreement between ENETS guidelines and the multidisciplinary tumor board for complementary RHC was 89%. In all, 100 (25%) patients underwent RHC with LN resection, 26 of whom had LN+. Tumor size (best cut-off at 1.95 cm), lymphovascular and perineural invasion, and pT classifications were associated with LN+. Among the 44 patients who underwent RHC for a tumor of 1 to 2 cm in size, 8 (18%) had LN+. No predictive factor of LN+ (base, resection margins, grade, mesoappendix, lymphovascular, perineural involvement) was found in this subgroup of patients.

Conclusions: In the largest study using the latest pathological criteria for completion RHC in A-NET, a quarter of patients had residual tumor. Further studies are warranted to demonstrate the survival impact of RHC in this setting.
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http://dx.doi.org/10.1097/SLA.0000000000002736DOI Listing
July 2019

Sexual health and needs for sexology care in digestive cancer patients undergoing chemotherapy: a 4-month cross-sectional study in a French University Hospital.

Support Care Cancer 2018 Aug 14;26(8):2889-2899. Epub 2018 Mar 14.

EA 3694 Human Fertility Research Group, Université Toulouse 3 Paul Sabatier, CHU Toulouse Paule de Viguier - Reproductive Medicine Department, 330 avenue de Grande-Bretagne, TSA 70034, 31059, Toulouse cedex 9, France.

Purpose: To assess sexual health and needs for sexology care of cancer patients during chemotherapy.

Methods: We performed a 4-month cross-sectional study in cancer patients treated by chemotherapy in the digestive cancer department of a regional university hospital. Patients were asked to fill out a self-administered questionnaire about their sexual health, Sexual Quality of Life Questionnaire for Male (SQoL-M) or Female (SQoL-F), and their needs for sexology care.

Results: The study sample was composed of 47 men and 31 women. Tumor locations were 36 colorectal (46%), 23 pancreatic (30%), and 19 other digestive cancers (24%). SQoL scores were lower in women (p < .001), in pancreatic and colorectal tumors (p = .041 and p = .033, respectively) compared to other digestive cancers, and in less-educated patients (p = .023). During chemotherapy, 40% of sexually active patients had less frequent sexual intercourse than before diagnosis, and 33% had completely stopped sexual activity. Sexuality care was desired by 44% of respondents. Among them, 83% favored a consultation with a medical sexologist and 63% with a psycho-sexologist, 54% wanted couple therapy, and 31% considered support groups. Patients with colorectal cancer had more frequent sexual intercourse without penetration at the time of survey (p = .036) and more often wanted couple therapy than patients with pancreatic cancer (p = .048).

Conclusions: This study is the first determination of sexual health and sexual quality of life in digestive cancers. Targets for interventions during chemotherapy for digestive cancers include populations with lower sexual quality of life: women, pancreatic sites, patients with sexual troubles during chemotherapy, and less-educated patients.
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http://dx.doi.org/10.1007/s00520-018-4125-1DOI Listing
August 2018
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