Weekly paclitaxel as a single agent or in combination with carboplatin or weekly topotecan in patients with resistant ovarian cancer: The CARTAXHY randomized phase II trial from groupe dinvestigateurs nationaux pour letude des cancers ovariens (GINECO)
Lortholary A.,Center Catherine Of Sienne |
Largillier R.,Center Azureen Of Cancerologie |
Weber B.,Center Alexis Vautrin |
Gladieff L.,Institute Claudius Regaud |
And 6 more authors.
Annals of Oncology | Year: 2012
Background: Platinum rechallenge or weekly topotecan in combination have not been evaluated in randomized trials for resistant recurrent ovarian cancer (ROC). Methods: Patients with ROC after first- or second-line treatment including a platinum and taxane and progression within 6 months were randomized to weekly paclitaxel (wP, 80 mg/m. 2/week) alone or in combination with carboplatin (C, area under the curve of 5 mg/ml/min every 4 weeks) or weekly topotecan (wT, 3 mg/m 2/week). Primary end point was progression-free survival (PFS) comparing wP and combination therapy. Results: Patients (n = 165) received a median three cycles in each arm. Nonhematologic toxicity was not different, except increased hypersensitivity reactions with wP + C. Grade 3-4 hematologic toxic effects with wP, wP + C, and wP + wT, respectively, were neutropenia in 13%, 54%, and 42%; febrile neutropenia in 0%, 4%, and 5%; and anemia in 6%, 19%, and 29%. Response rates were 35%, 37%, and 39%, and median PFS times were 3.7, 4.8, and 5.4 months, respectively. PFS was not significantly different among the treatment arms [hazard ratio (HR) 0.922; 95% confidence interval (CI) 0.765-1.111; P = 0.46] or between monotherapy and combination therapy (HR 0.951; 95% CI 0.686-1.318; P = 0.76). Conclusions: Combination chemotherapy in platinum-resistant ROC was more toxic than weekly paclitaxel and did not significantly prolong PFS. © The Author 2011. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
PubMed | Institute Sainte Catherine, Institute Paoli Calmettes, Center Antoine Lacassagne, Service Route and Center Azureen Of Cancerologie
Type: Journal Article | Journal: Cancer radiotherapie : journal de la Societe francaise de radiotherapie oncologique | Year: 2015
Rectal cancer is increasingly prevalent in elderly patients. Their clinical history and outcome after treatment are poorly described. This retrospective study was undertaken to provide more data and to compare therapeutic strategies to the standard of care for younger patients.Patients concerned were aged 80 years or older, with a rectal cancer diagnosed between 2006 and 2008 and treated in Provence-Alpes-Cte-dAzur (PACA), irrespective of stage and treatment of the disease. Overall survival and relapse-free-survival were correlated with patients characteristics and treatment. The adopted therapeutic strategy was then compared to the standard-of-care for younger patients.With a median follow-up of 36 months, among the 160 patients included, the 3-year overall survival and relapse-free survival were 59.2% and 76.6%, respectively for the 117 patients who received a treatment with curative intent. In the multivariate analysis, node status and surgery independently influenced overall survival, while relapse-free survival was influenced by age, N status, and gender. For T0-T2 tumours, patients were treated similarly to younger patients with an overall survival of 83.6% and a relapse-free survival of 95.2%. For T3-T4 tumours, the 3-year relapse-free survival was 65%, even with a less aggressive strategy.Surgical resection after evaluation using the Comprehensive Geriatric Assessment (CGA) test should be the standard treatment for localized rectal cancer (T0-T2) in elderly patients, as it is in younger patients. For locally advanced lesions (T3-T4), results obtained after a conservative approach suggest that a non-surgical strategy can be used in elderly patients.
PubMed | Center Azureen Of Cancerologie, Center Antoine Lacassagne and Nice University Hospital Center
Type: Journal Article | Journal: Bulletin du cancer | Year: 2016
Depression is a sustainable state of deep sadness and abatement. It is frequently identified in patients with cancer and often undervalued by oncologists. The reduced PRIME-MD questionnaire is a questionnaire of 2 items validated in French. However, it has been neither translated nor validated in French. The objective of our study is to translate the PRIME-MD and validate it into French.The PRIME-MD questionnaire was translated into French by using the recommendations of the EORTC and compared to the French gold standard questionnaire Mini-International Neuropsychiatric Interview (MINI).Two hundred and ninety-nine patients were included in our study. With a 98% filling rate, the Q2i questionnaire has been well accepted. The prevalence of depression in our population was measured at 7.4%. With a sensitivity of 89.47%, a specificity of 58.85%, found percentages are equal to those of the questionnaire in English. The negative predictive value was measured at 98.52%.This study demonstrates that the Q2i questionnaire is a quick and easy screening tool, requiring less than 2minutes to target patients likely to benefit from psychological support.
PubMed | Center Azureen Of Cancerologie, Kantar Health, Clinique Clementville, Clinique Saint Pierre and 8 more.
Type: Journal Article | Journal: European journal of cancer care | Year: 2016
The question of returning to work and pursuing professional activity during cancer treatment is an increasingly important consideration. The present work focuses on factors affecting the feasibility of maintaining professional activity during treatment for breast cancer, for women who wished to do so. Written questionnaires were collected from 216 patients between March and November 2012. Since the onset of their treatment, 31.4% of the women (68/216) had not been on sick-leave. The main factors associated with the pursuit of professional activity were: considering the availability of their physician to answer questions as unimportant [OR=18.83 (3.60-98.53); P0.05]; considering the diagnosis of cancer as likely to have a weak impact on career perspectives [OR=4.07 (2.49-6.64); P0.05]; not having any children in the household [OR=3.87 (2.38-6.28); P0.05]; being in a managerial position [OR=3.13 (1.88-5.21); P0.05]. Negative predictive factors were: physician mentioning adverse effects of the treatment [OR=0.31 (0.16-0.58); P0.05], and patient rating workload as high [OR=0.26 (0.15-0.46); P0.05]. As a result of advances in therapeutic strategies, more patients will expect healthcare professionals, as well as employers and occupational health societies, to prioritise issues pertaining to the maintenance of professional activities during cancer treatment.
Wagner U.,University of Marburg |
Marth C.,Innsbruck Medical University |
Largillier R.,Center Azureen Of Cancerologie |
Kaern J.,Norwegian Radium Hospital |
And 8 more authors.
British Journal of Cancer | Year: 2012
Background: The CALYPSO phase III trial compared CD (carboplatin-pegylated liposomal doxorubicin (PLD)) with CP (carboplatin-paclitaxel) in patients with platinum-sensitive recurrent ovarian cancer (ROC). Overall survival (OS) data are now mature.Methods:Women with ROC relapsing 6 months after first-or second-line therapy were randomised to CD or CP for six cycles in this international, open-label, non-inferiority trial. The primary endpoint was progression-free survival. The OS analysis is presented here.Results:A total of 976 patients were randomised (467 to CD and 509 to CP). With a median follow-up of 49 months, no statistically significant difference was observed between arms in OS (hazard ratio0.99 (95% confidence interval 0.85, 1.16); log-rank P=0.94). Median survival times were 30.7 months (CD) and 33.0 months (CP). No statistically significant difference in OS was observed between arms in predetermined subgroups according to age, body mass index, treatment-free interval, measurable disease, number of lines of prior chemotherapy, or performance status. Post-study cross-over was imbalanced between arms, with a greater proportion of patients randomised to CP receiving post-study PLD (68%) than patients randomised to CD receiving post-study paclitaxel (43%; P=0.001).Conclusion:Carboplatin-PLD led to delayed progression and similar OS compared with carboplatin-paclitaxel in platinum-sensitive ROC. © 2012 Cancer Research UK All rights reserved.
Weber B.,Center Alexis Vautrin |
Largillier R.,Center Azureen Of Cancerologie |
Ray-Coquard I.,Center Leon Berard and 4128 |
Yazbek G.,Institute Jean Godinot |
And 8 more authors.
Supportive Care in Cancer | Year: 2013
Purpose: A prospective phase II multicenter study was performed in two steps in paclitaxel-treated ovarian cancer patients in France. A French version of the four-item Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire was validated. This was then used to evaluate neurotoxicity in relation to erythropoietin treatment. Methods: Patients received standard second-line paclitaxel-based chemotherapy and erythropoietin for anemia. Neurotoxicity and hemoglobin levels were evaluated every cycle with the FACT/GOG-Ntx and NCI-CTCAE. The translated questionnaire was tested in 20 patients to confirm the translation accuracy. The final questionnaire was validated in 98 patients with internal consistency (Cronbach's coefficient) and item correlation (Pearson's r coefficient) tests. Neurotoxicity severity was analyzed according to erythropoietin intake (first three cycles versus no or late intake) and correlated with anemia. Results: Patients received a median of six paclitaxel cycles (range 1-9). Neurotoxicity was validated in 484 questionnaires. Internal consistency was excellent with Cronbach's coefficients of ≥0.89 at inclusion, after 3 cycles and at study end. Inter-question correlation was high with Pearson's coefficients of 0.65-0.85. FACT/GOG-Ntx and NCI-CTCAE severity scoring was similar. Globally, the incidence of severe neurotoxicity (FACT/GOG-Ntx and NCI-CTCAE) was found significantly higher in patients with severe anemia. Of 98 evaluable patients, 31 received erythropoietin during the first three cycles. Mean hemoglobin level was significantly lower in this group from baseline to cycle 4; however, these anemic patients with early EPO intake did not develop an increase rate of severe neurotoxicity. Conclusions: The French FACT/GOG-Ntx questionnaire is a reliable and valid tool for assessing chemotherapy-induced neuropathy. This study raises the possibility that erythropoietin might play a neuroprotective role when administered with paclitaxel. © 2013 Springer-Verlag Berlin Heidelberg.
Cowen D.,Timone Hospital |
Gross E.,Timone Hospital |
Rouannet P.,Center Val dAurelle |
Teissier E.,Center Azureen Of Cancerologie |
And 6 more authors.
Breast Cancer Research and Treatment | Year: 2010
The objective is to prospectively determine the factors responsible for reconstruction failure and capsular contracture in mastectomized breast cancer patients who underwent immediate two-stage breast reconstruction with a tissue expander and implant, followed by radiotherapy. This is a multicenter, prospective, non-randomized study. Between February 1998 and September 2006, we prospectively examined 141 consecutive patients, each of which received an implant after mastectomy, followed by chest wall radiotherapy at 46-50 Gy in 23-25 fractions. Radiotherapy was delivered during immediate post-mastectomy reconstruction. Patients were evaluated by both a radiation oncologist and a surgeon 24-36 months after treatment. The median follow-up duration was 37 months. According to Baker's classification, capsular contracture was grade 0, 1, or 2 in 67.5% of cases; it was grade 3 or 4 in 32.5% of cases. In total, 32 breast reconstruction failures required surgery. In univariate analysis, the following factors were associated with Baker grade 3 and 4 capsular contraction: adjuvant hormone therapy (P = 0.02), the surgeon (P = 0.04), and smoking (P = 0.05). Only one factor was significant in multivariate analysis: the surgeon (P = 0.009). Three factors were associated with immediate post-mastectomy breast reconstruction failure in multiple logistic regression analysis: T3 or T4 tumors (P = 0.0005), smoking (P = 0.001), and pN+ axillary status (P = 0.004). Patients with none, 1, 2, or all 3 factors have a probability of failure equal to 7, 15.7, 48.3, and 100%, respectively (P = 3.6 x 10-6). The model accurately predicts 80% of failures. Mastectomy, immediate reconstruction (expander followed by implant), and radiotherapy should be considered when conservative surgery is contraindicated. Three factors may be used to select patients likely to benefit from this technique with a low failure rate. © Springer Science+Business Media, LLC. 2009.
Extra J.-M.,Institute Paoli Calmettes |
Antoine E.C.,Service de Chimiotherapie |
Vincent-Salomon A.,University Pierre and Marie Curie |
Delozier T.,Center Francois Balcesse |
And 13 more authors.
Oncologist | Year: 2010
Background. The Hermine study observed the use of trastuzumab for metastatic breast cancer (MBC) in routine practice, including patients who received trastuzumab treatment beyond progression (TBP). Patients and Methods. The study observed 623 patients for ≥2 years. Treatment was given according to oncologists' normal clinical practices. Endpoints included duration of treatment, efficacy, and cardiac safety. The TBP subanalysis compared overall survival (OS) in 177 patients who received first-line trastuzumab and either continued trastuzumab for ≥30 days following progression or stopped at or before progression. Results. The median treatment duration was 13.3 months. In the first-, second-, and third-line or beyond treatment groups, the median time to progression (TTP) were 10.3 months, 9.0 months, and 6.3 months, and the median OS times were 30.3 months, 27.1 months, and 23.2 months, respectively. Heart failure was observed in 2.6% of patients, although no cardiacassociated deaths occurred. In the TBP subanalysis, the median OS duration from treatment initiation and time of disease progression were longer in patients who continued receiving trastuzumab TBP (>27.8 months and 21.3 months, respectively) than in those who stopped (16.8 months and 4.6 months, respectively). However, the groups were not completely comparable, because patients who continued trastuzumab TBP had better prognoses at treatment initiation. The median TTP was longer in patients who continued trastuzumab TBP (10.2 months) than in those who stopped (7.1 months). Conclusion. The Hermine findings confirm that the pivotal trials of first-line trastuzumab treatment in MBC patients are applicable in clinical practice. The subanalysis suggests that trastuzumab TBP offers a survival benefit to MBC patients treated with first-line trastuzumab. © AlphaMed Press.
Belkacemi Y.,University Paris Est Creteil |
Fourquet A.,University Pierre and Marie Curie |
Cutuli B.,Clinique de Courlancy |
Bourgier C.,Institute Gustave Roussy |
And 7 more authors.
Critical Reviews in Oncology/Hematology | Year: 2011
Purpose: While new strategies for the treatment of invasive breast cancer (BC) are emerging, radiotherapy (RT) modalities are still under debate. The French expert review board of Nice-Saint-Paul de Vence was asked firstly to conduct a qualitative evidence-based systematic review and then to establish clinical practice guidelines for the use of post operative RT in invasive BC. Methods and materials: A search to identify eligible studies was undertaken using the Medline® database. All phase III randomized trials and systematic reviews evaluating the role and modalities of RT in invasive BC were included, together with some noncontrolled studies if no randomized trials were identified. The quality and clinical relevance of the studies were evaluated to determine the level of evidence. Results: The maximum delay between surgery and RT should ≤8 weeks when chemotherapy (CT) is not indicated. This should not exceed 24 weeks when adjuvant CT is administered. Whole breast RT delivering 50. Gy in 25 fractions followed by a boost of 10-16. Gy remains the standard of care after conservative surgery (CS). In the elderly population, for certain cases presenting comorbidities associated with a limited life expectancy, RT indication (even hypofractioned) and boost delivery may be unnecessary in the light of an unfavourable risk/benefit ratio. RT technique and indications should not vary in case of neoadjuvant CT followed by CS. After total mastectomy, RT should be indicated in N+ and in N- patients with high risk of local recurrence. The experts recommend to initiate tamoxifen at the end of RT, while aromatase inhibitors could be administered either concomitantly or sequentially with RT. There is no consistent data to delay (or suspend) trastuzumab administration during RT. As for all patients, in case of concurrent RT-trastuzumab administration, reduction of cardiac tissues exposure is highly recommended. After breast reconstruction, RT should be delivered as after standard CS without boost. Conclusion: Due to significant variations in practice in the treatment of patients with BC, our group aimed to provide guidelines for clinical practice. The systematic review of the literature formed the basis of our evidence-based recommendations; however expert agreements were necessary on those subjects that are still under debate. Our group will update these guidelines every 4 years, taking in consideration new advances in technology, new drugs administration, biologic tools and innovative therapeutic options. © 2010 Elsevier Ireland Ltd.
PubMed | Center Azureen Of Cancerologie, Center Paul Strauss, Institute Gustave Roussy, University of Paris Descartes and 3 more.
Type: Journal Article | Journal: Bulletin du cancer | Year: 2014
Adjuvant chemotherapy for localised breast cancer aims at reducing the risk of relapse and at increasing overall survival. Decision criteria include tumour burden and biological profile. It appears currently difficult to evaluate the benefit/risk ratio in certain borderline cases, which are more and more frequent. We have evaluated through an anonymous web survey conducted as part of the 2013 Annual Saint-Paul-de-Vence breast conference, the chemotherapy decisions, use of guidelines and level of certainty with decisions in this type of situation through four clinical cases. The survey was proposed to 1,190 French physicians who are directly in charge of breast cancer care, whatever their specialty. Three hundred and fifty-three of them replied, of whom 67 % were oncologists and 15 % surgeons. A significantly heterogeneous decision was observed for two out of four cases, in which 52 and 69 % of the physicians opted for adjuvant chemotherapy, versus 48 and 21 % for abstention respectively. Eighty seven percent of responding physicians used guidelines to guide their decision. These guidelines were regional for 63 %, national for 36 %, local in 21 % and international in 16 % of the cases. The level of certainty varied with clinical cases but not with the physicians specialty, nor type of decision.