Impact of early palliative care on additional line of chemotherapy in metastatic breast cancer patients: results from the randomized study OSS.

PURPOSE: The most appropriate criteria and timing for palliative care referral remain a critical issue, especially in patients with metastatic breast cancer for whom long-term chemosensibility and survival are observed. We aimed to compare the impact of early palliative care including formal concertation with oncologists on decision for an additional line of chemotherapy compared with usual oncology care. METHODS: This randomized prospective study enrolled adult women with metastatic breast cancer and visceral metastases with a 3rd- or 4th-line chemotherapy (CT). Patients received usual oncology care with a palliative care consultation only upon patient or oncologist request (standard group, S) or were referred to systematic palliative care consultation including a regular concertation between palliative care team and oncologists (early palliative care group, EPC). The primary endpoint was the rate of an additional CT (4th or 5th line) decision. Quality of life, symptoms, social support and satisfaction were self-evaluated at 6 and 12 months, at treatment discontinuation or 3 months after discontinuation. RESULTS: From January 2009 to November 2012, two authorized cancer centers included 98 women (EPC: 50; S: 48). Thirty-seven (77.1%, 95%CI 62.7-88%) patients in the EPC group had a subsequent chemotherapy prescribed and 36 (72.0%, 95%CI 57.5-83.8%) in the S group (p = 0.646). No differences in symptom control and global quality of life were observed, but less deterioration in physical functioning was reported in EPC (EPC: 0 [- 53-40]; S: - 6; 7 [- 60 to - 20]; p = 0.027). Information exchange and communication were significant improved in EPC (exchange, EPC: - 8.3 [- 30 to + 7]; S: 0.0 [- 17 to + 23]; p = 0.024; communication, EPC: 12.5 [- 8 to - 37]; S: 0.0 [- 21 to + 17]; p = 0.004). CONCLUSION: EPC in metastatic breast cancer patients did not impact the prescription rate of additional chemotherapy in patients a 3rd- or 4th-line chemotherapy for metastatic breast cancer; however, EPC may contribute to alleviate deterioration in physical functioning, while facilitating communication. TRIAL REGISTRATION: ClinicalTrial.gov identifier: NCT00905281, May 20, 2009.

Feasibility of an exercise and nutritional intervention for weight management during adjuvant treatment for localized breast cancer: the PASAPAS randomized controlled trial.

PURPOSE: Lack of physical activity (PA), weight gain, and overweight have been associated with increased risk of recurrence and mortality after breast cancer diagnosis. We evaluated the feasibility of implementing an individualized exercise program and nutritional counseling during adjuvant treatment of localized invasive breast cancer. METHODS: Sixty-one patients eligible for adjuvant chemotherapy were randomized 2:1 to receive a 6-month program of weekly aerobic exercises associated with nutritional counseling (n = 41) or usual care with nutritional counseling (n = 20, one withdrawal). The primary endpoints were the proportion of patients compliant with two weekly supervised sessions and their overall adherence (i.e., proportion of supervised and unsupervised sessions completed versus planned sessions). RESULTS: Ten percent of patients in the intervention group were compliant with the two weekly supervised sessions for 6 months, but the overall median adherence rate was 85% of supervised and non-supervised sessions completed. Non-adherence was mainly due to intrinsic reasons (medical, organizational, psychological barriers). Adherence was positively associated with education and baseline PA level and inversely associated with baseline weight and tumor grade. No statistically significant benefits were observed in the intervention group, even if overall PA level and body composition improved and anthropometrics were maintained over time (p < 0.05). CONCLUSIONS: Overall, there was good adherence with the 6-month exercise program during adjuvant treatment for breast cancer, despite poor compliance to twice-weekly supervised sessions. This study highlights the need for flexible exercise modalities and innovative experimental design to reach patients who would most adhere and benefit from intervention. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01331772. Registered 8 April 2011, https://clinicaltrials.gov/ct2/show/NCT01331772?term=pasapas&rank=1.

Systematic Screening for Occupational Exposures in Lung Cancer Patients: A Prospective French Cohort.

Occupational lung cancers are under-reported and under-compensated worldwide. We assessed systematic screening for occupational exposure to carcinogens combining a self-administered questionnaire and an occupational consultation to improve the detection of occupational lung cancers and their compensation. Social deprivation and the costs of this investigation were estimated. Patients with lung cancer received a self-administered questionnaire to collect their job history, potential exposure to carcinogens and deprivation. A physician assessed the questionnaire and recommended an occupational consultation if necessary. During the consultation, a physician assessed if the lung cancer was work-related and, if it was, delivered a medical certificate to claim for compensation. Over 18 months, 440 patients received the self-administered questionnaire: 234 returned a completed questionnaire and a consultation was required for 120 patients. Compensation was judged possible for 41 patients. Among the 35 medical certificates delivered, 19 patients received compensation. Nearly half the patients (46%) were assessed as socially deprived and these patients took significantly longer to return the questionnaire compared with those who were not deprived. The mean cost of the process was €62.65 per patient. Our results showed a systematic self-administered questionnaire can be used to identify patients potentially exposed to carcinogens and to improve compensation.

[Assessment of a self-administered questionnaire identifying occupational exposures among lung cancer patients]. / Évaluation d'un auto-questionnaire de repérage des expositions professionnelles chez les patients atteints de cancer bronchopulmonaire.

Ten to 29% of lung cancers might be linked to occupational factors but 60% of them are not compensated. The PROPOUMON project aimed to improve the identification, recognition and compensation of occupational lung cancer as occupational disease using a self-administered questionnaire (AQREP). One objective was to assess the AQREP, comparing it with the questionnaire drawn up by the French Language Pneumology Society (Q-SPLF). From March 2014 to September 2015, 90 lung cancer patients treated at the Centre Léon-Bérard responded to the AQREP and Q-SPLF. The two physicians in charge of the consultation assessed independently whether or not a consultation was indicated. A certificate for the compensation process was proposed when a suspicion of high or average imputability was identified. Analysis of the questionnaires was concordant for 73% of the patients. The AQREP has a sensitivity of 72% and a specificity of 73%. Its positive and negative predictive values were 62 and 82%. The information provided by 24 patients were discordant between questionnaires. In two patients with discordant evaluation (AQREP+/Q-SPLF-; AQREP-/Q-SPLF+), one Initial Medical Certificate (IMC) was written. This study made it possible to conclude that AQREP is relevant for the identification of potentially occupational lung cancers. Collegial discussion of complex cases might be considered. The project is currently been extended to other centers and to lymphoma.

[Identification of occupational exposures among patients with lung cancer]. / Repérage des expositions professionnelles chez les patients atteints de cancers bronchopulmonaires.

Despite the rising number of lung cancers recognized as occupational disease, occupational lung cancers are still under-reported. To improve the recognition of occupational lung cancer, we implemented at the Léon-Bérard Cancer Centre, a questionnaire-based process to identify occupational exposures in these patients and improve compensation. Between January 2010 and December 2011, 91 lung cancer patients responded to a questionnaire. An "occupational cancer" consultation was proposed to patients reporting exposure to carcinogens or jobs with risk of exposure. Fifty-one patients were seen in consultation (34 following the questionnaire and 17 directly addressed by the oncologist). A suspicion of high or average imputability was identified in 31 (60.8%) patients and a compensation process seemed possible for 27 (61.4%). Asbestos was the most common carcinogen identified. Among 17 compensation processes engaged, 12 succeeded and one is ongoing. The complexity of the administrative process seems to be an obstacle for patients and perpetuates inequality. The implementation of our approach increased the identification and the compensation of occupational lung cancer. Our approach responds to the objectives of the National Cancer Plan and helps to improve the overall care of patients with cancer. This approach has been awarded by the national label in 2011 "Year of the patients and their rights".

Validation of prognostic scores for survival in cancer patients beyond first-line therapy.

BACKGROUND: We aimed to validate prognostic scores for survival in patients undergoing chemotherapy for advanced or metastatic cancer after first-line treatment. METHODS: We previously described two models with good prognostic value based on a combination of Performance Status (PS) and either lactate dehydrogenase (LDH) level or lymphocyte count. These factors were evaluated for their ability to predict overall survival (OS) in a prospective cohort of 299 patients. Clinical and blood parameters were prospectively recorded. Candidate prognostic factors for OS with 0.05 significance level in univariate analysis were included in a multivariate Cox model. RESULTS: Median age was 59 years (range: 26-85). Primary tumor sites were breast (45%), lung (15%), ovaries (11%) and others (29%). The number of metastatic sites was 1 (29%), 2 (48%), >2 (23%). Median follow-up and median OS were 12 and 6 months, respectively. Multiple regression analysis confirmed that PS >1, lymphocyte count ≤700/µL and LDH >600 UI/L were independent predictors of short OS, as well as interleukin 6 (IL-6) level, serum albumin concentration and platelet count. CONCLUSIONS: Prognostic scores using PS plus LDH level or PS plus lymphocyte count were validated for predicting survival in metastatic cancer patients in relapse beyond first-line treatment. A score combining PS, LDH, lymphocyte and platelet count, serum albumin and IL-6 level was superior in determining patients' prognosis.

Factors of interrupting chemotherapy in patients with Advanced Non-Small-Cell Lung Cancer.

BACKGROUND: Little is known about prognosis of metastatic patients after receiving a first-line treatment and failure. Our group already showed in pre-treated patients enrolled in phase I clinical trials that a performance status (PS) > 2 and an LDH > 600 UI/L were independent prognostic factors. In this prospective study, which included 45 patients, we identified clinical and biological variables as outcome predictors in metastatic Non-Small Cell lung cancer after first line chemotherapy were identified. FINDINGS: Forty-five patients that were previously treated for metastatic disease from 12/2000 to 11/2005 in the comprehensive cancer centre (Centre Léon Bérard). Clinical assessment and blood parameters were recorded and considered. Patient prognostic factors for overall survival (OS) with a 0.05-significance level in univariate analysis were entered in a multivariate Cox model for further analysis.Patients' median age was 58.5 years (range: 37 - 76). Sixty two percent of the patients were PS = 0 or 1. After inclusion, nine patients received second-line (22.5%), and two received third-line chemotherapy (5%). Univariate analysis showed that the factors associated with reduced OS were: PS > 2, weight loss >10%, more than one line of chemotherapy treatment and abnormal blood parameters (hemoglobin (Hb), platelet and neutrophils counts). Multiple regression analysis confirmed that PS > 2 and abnormal hemoglobin were independent predictors for low overall survival. According to the presence of none (33%), 1 (37%) and 2 (30%) prognostic factors, median OS were 12, 5 and 2 months respectively. CONCLUSION: From this prospective study, both PS and anemia were found as independent determinants of survival, we found that both PS and anemia were independent determinants of survival. The combination of poor PS and anemia is an effective strategy to predict survival in the case of patients with metastatic NSCLC receiving further treatment after the first line.

[Prospective study on the quality of care and quality of life in advanced cancer patients treated at home or in hospital: intermediate analysis of the Trapado study]. / Etude prospective de qualité des soins et de qualité de vie chez des patients cancéreux en phase palliative, en hospitalisation ou à domicile: analyse intermédiaire de l'étude Trapado.

The preferences of advanced cancer patients and the impact of cancer management on relatives remain partly unknown. We present the preliminary results of a prospective study evaluating quality of care (QC), quality of life (QoL) and family impact (FI) in advanced cancer patients treated at home or in hospital, depending on their own choice. QC is evaluated using STAS questionnaire, and QoL and symptom control using EORTC QLQ-C30, Spielberger questionnaire and VAS for pain evaluation. FI is evaluated using GHQ28 and semi-structured interviews conducted at days 0, 15, 30, then monthly until death. Intermediate analysis of 52 patients (100 expected) of whom 63 % had chosen home care, 26 % in-hospital care. Actual assignment is home care: 56 %, in-hospital care: 44 %. Place of death is home: 15 %, hospital: 85 %. In the QC study, the two symptoms most frequently rated by nurses are anxiety and pain, in either group. Patient information and communication are also similar in both groups. The QoL and symptom study shows that patients also rate pain as frequent (84 %) but moderate (mean VAS score 2.5/10). However, the most frequent symptom is fatigue (100 %). Anxiety is rated higher at hospital, as well as FI (anxiety, insomnia, social dysfunction and global score). Palliative care research is sometimes difficult but feasible. In this study, most patients prefer home care. Anxiety and FI seem lower at home. However, re-hospitalisations just before death are frequent and death generally occurs in hospital.

Gefitinib (IRESSA) with vinorelbine or vinorelbine/cisplatin for chemotherapy-naive non-small cell lung cancer patients.

This phase I study assessed the safety, pharmacokinetics, and efficacy of gefitinib (IRESSA) combined with vinorelbine or vinorelbine/cisplatin in chemotherapy-naive patients with advanced non-small cell lung cancer (NSCLC). Patients received gefitinib 250 mg/day and vinorelbine (group A; n = 6) or vinorelbine/cisplatin (group B; n = 8). An additional set of group B patients (n = 9) received gefitinib 500 mg/day with vinorelbine/cisplatin. Adverse events were consistent with individual treatments of gefitinib (mild reversible rash, diarrhea) and chemotherapy (asthenia, fever, nausea, vomiting, constipation), although there was a higher than expected incidence of Common Toxicity Criteria grade 3 or 4 hematologic adverse events, specifically febrile neutropenia and neutropenia. Pharmacokinetic data suggested that neither of the chemotherapy regimens affected steady-state exposure to gefitinib and also that steady-state gefitinib did not alter exposure to vinorelbine or cisplatin. Objective, durable antitumor activity was observed: five partial responses (one in group A; four in group B) and six patients with stable disease (all in group B). The safety data demonstrated that gefitinib with vinorelbine or vinorelbine/cisplatin resulted in severe myelosuppression leading to an unacceptable rate of febrile neutropenia. This study does not support the concurrent administration of gefitinib and vinorelbine, with or without cisplatin, as a valid treatment for advanced NSCLC.