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Rennes, France

Gross-Goupil M.,University Paris - Sud | Fourcade A.,University Paris - Sud | Blot E.,Center Henri Bequerel | Penel N.,Center Oscar Lambret | And 11 more authors.
European Journal of Cancer | Year: 2012

Purpose: To compare the overall survival rates of good-prognosis carcinomas of an unknown primary site (CUPS) patients treated with cisplatin alone (C) or in combination with gemcitabine (CG). Patients and methods: Good prognosis was defined according to the GEFCAPI (Groupe d'Etude Franais des Carcinomes de site Primitif Inconnu) classification by PS (Performance Status) ≤1 and LDH (Lactate Deshydrogenase) within the normal range. Patients were randomly assigned to receive C or CG. Patients in the C arm received cisplatin 100 mg/m2 repeated every 3 weeks. In the CG arm, chemotherapy consisted of gemcitabine 1250 mg/m2 on days 1 and 8 and cisplatin 100 mg/m 2 IV on day 1, repeated every 3 weeks. The original plan was to accrue 192 patients in order to detect a 20% difference in overall survival. Results: Fifty-two patients were enrolled (arm A: 25; arm B: 27). The trial was stopped early due to insufficient accrual. The median overall survival (OS) rate was 11 months [95% confidence interval: 9-20] and 8 months [95% CI: 6-12], in the CG arm and in the C arm, respectively. The 1-year survival rate was 46% [95% CI: 28-64] in the combination arm and 35% [95% CI: 19-56] in the C arm (log rank test: p = 0.73). The median progression-free survival (PFS) rate was 5 [95% CI: 3-11] and 3 [95% CI: 1-8] months in the CG and in the C arm, respectively. The 1-year PFS rate was 29% [95% CI: 15-48] in the combination arm and 15% [95% CI: 5-35] in the C arm (log rank test: p = 0.27). No toxic deaths occurred. Grade 3-4 neutropenia (63% versus 12%) and grade 3-4 thrombocytopenia (37% versus 4%) were more frequent in the CG arm than in the C arm. Conclusion: A non-significantly better outcome was observed with CG as compared to C in patients with CUP and a non-unfavourable prognosis. The toxicity profile of the combined arm was represented by haematologic toxicity with thrombocytopenia and leuconeutropenia. International collaboration is required to conduct phase III trials in patients with CUP. © 2011 Elsevier Ltd. All rights reserved. Source

Guilcher M.A.-L.,Center Rene Gauducheau | Prevost B.,Center Oscar Lambret | Sunyach M.P.,Center Leon Berard | Peiffert D.,Center Alexis Vautrin | And 7 more authors.
International Journal of Radiation Oncology Biology Physics | Year: 2011

Purpose: To evaluate the efficacy and toxicity of high-dose-rate (HDR) brachytherapy in patients with inoperable endobronchial carcinoma. Methods and Materials: We retrospectively reviewed the records (April 1991 - May 2004) of patients with non-small-cell carcinoma, with no extrabronchial spread on computed tomography scans, who underwent HDR brachytherapy because of contraindications to surgery and external beam radiation therapy. Kaplan-Meier survival curves were compared by the log-rank test. Prognostic factors were analyzed by multivariate analysis. Results: 226 patients (223 men, 3 women, mean age: 62.2 years (range, 40-84)) were included. Of those, 217 (97%) had squamous cell carcinoma (Tis/T1/T2/Tx: 60/153/9/4). Dose was prescribed at 1 cm from the radius (24-35 Gy in 4-6 fractions). Mean follow-up was 30.4 months (range, 9-116). Complete endoscopic response rate was 93.6% at 3 months. One hundred twenty-eight patients (56%) died of intercurrent disease (n = 45), local failure (n = 36), metastasis (n = 10), local failure and metastasis (n = 11), complications (n = 13), and other causes (n = 12). The 2-year and 5-year survival rates were, respectively, 57% and 29% (overall) (median, 28.6 months), 81% and 56% (cancer-specific), and 68% and 50% (local disease-free). Acute toxicity included pneumothorax (1.5%) and mucosal inflammation (10%). Late complications were hemoptysis (6.6% with 5% of fatalities), bronchitis (19.5%), and necrosis (3.5%). In multivariate analysis, a distal tumor location and the use of two catheters were associated with improved local disease-free survival (p = 0.003 and p = 0.007, respectively) and a distal tumor location with improved overall survival (p = 0.0001). Conclusions: This large retrospective study confirms that HDR brachytherapy is an efficient and safe treatment in patients with inoperable endobronchial carcinoma. Copyright © 2011 Elsevier Inc. Source

Fizazi K.,University Paris - Sud | Lesaunier F.,Center Franois Baclesse | Delva R.,Center Paul Papin | Gravis G.,Institute Paoli Calmettes | And 17 more authors.
European Journal of Cancer | Year: 2012

Aim: To assess docetaxel-estramustine in patients with localised high-risk prostate cancer. Patients and methods: After staging pelvic lymph node dissection, patients with high-risk prostate cancer randomly received androgen deprivation therapy (ADT) (3 years) + DE (4 cycles of docetaxel 70 mg/m 2/3 weeks + estramustine 10 mg/kg/d d1-5) or ADT alone. Local therapy was administered at 3 months. Results: Four hundred and thirteen patients were accrued: T3-T4 (67%), Gleason score ≥8 (42%), PSA >20 ng/mL (59%), pN+ (29%). In the chemotherapy arm, 94% of patients received the planned four cycles of docetaxel. Local treatment consisted of radiotherapy in 358 patients (87%) (median dose 74 Gy in both arms). ADT was given for 36 months in both arms. A PSA response (PSA ≤0.2 ng/mL after 3 months of treatment) was obtained in 34% and 15% in the ADT + DE arm and in the ADT arm, respectively (p < 0.0001). Febrile neutropenia occurred in only 2%. Moderate to severe hot flashes occurred less often in the ADT + DE arm (2% versus 22%; p < 0.001). There was no toxicity-related death, no secondary leukaemia, and no excess second cancers. Chemotherapy had a negative impact on quality of life (global health status, p = 0.01; fatigue, p = 0.003; role functioning, p = 0.003; social functioning, p = 0.006) at 3 months but this effect disappeared at 1 year. Conclusion: Docetaxel-estramustine can be combined safely with standard therapy in high-risk prostate cancer, with a promising PSA response rate and no negative impact on quality of life after 1 year. Long-term follow-up is required to assess the impact on relapse and survival. © 2011 Elsevier Ltd. All rights reserved. Source

Beckendorf V.,Center Alexis Vautrin | Guerif S.,University of Poitiers | Le Prise E.,Center Eugne Marquis | Cosset J.-M.,University Pierre and Marie Curie | And 13 more authors.
International Journal of Radiation Oncology Biology Physics | Year: 2011

Purpose: To perform a randomized trial comparing 70 and 80 Gy radiotherapy for prostate cancer. Patients and Methods: A total of 306 patients with localized prostate cancer were randomized. No androgen deprivation was allowed. The primary endpoint was biochemical relapse according to the modified 1997-American Society for Therapeutic Radiology and Oncology and Phoenix definitions. Toxicity was graded using the Radiation Therapy Oncology Group 1991 criteria and the late effects on normal tissues-subjective, objective, management, analytic scales (LENT-SOMA) scales. The patients' quality of life was scored using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item cancer-specific and 25-item prostate-specific modules. Results: The median follow-up was 61 months. According to the 1997-American Society for Therapeutic Radiology and Oncology definition, the 5-year biochemical relapse rate was 39% and 28% in the 70- and 80-Gy arms, respectively (p = .036). Using the Phoenix definition, the 5-year biochemical relapse rate was 32% and 23.5%, respectively (p = .09). The subgroup analysis showed a better biochemical outcome for the higher dose group with an initial prostate-specific antigen level >15 ng/mL. At the last follow-up date, 26 patients had died, 10 of their disease and none of toxicity, with no differences between the two arms. According to the Radiation Therapy Oncology Group scale, the Grade 2 or greater rectal toxicity rate was 14% and 19.5% for the 70- and 80-Gy arms (p = .22), respectively. The Grade 2 or greater urinary toxicity was 10% at 70 Gy and 17.5% at 80 Gy (p = .046). Similar results were observed using the LENT-SOMA scale. Bladder toxicity was more frequent at 80 Gy than at 70 Gy (p = .039). The quality-of-life questionnaire results before and 5 years after treatment were available for 103 patients with no differences found between the 70- and 80-Gy arms. Conclusion: High-dose radiotherapy provided a better 5-year biochemical outcome with slightly greater toxicity. © 2011 Elsevier Inc. Source

Zhu J.,Nanjing Southeast University | Zhu J.,Shandong Cancer Hospital and Institute | Zhang Z.-C.,Shandong Cancer Hospital and Institute | Li B.-S.,Nanjing Southeast University | And 7 more authors.
Radiotherapy and Oncology | Year: 2010

Purpose: To analyze acute esophagitis (AE) in a Chinese population receiving 3D conformal radiotherapy (3DCRT) for non-small cell lung cancer (NSCLC), combined or not with chemotherapy (CT), using the Lyman-Kutcher-Burman (LKB) normal tissue complication probability (NTCP) model. Materials and methods: 157 Chinese patients (pts) presented with NSCLC received 3DCRT: alone (34 pts) or combined with sequential CT (59 pts) (group 1) or with concomitant CT (64 pts) (group 2). Parameters (TD50, n, and m) of the LKB NTCP model predicting for > grade 2 AE (RTOG grading) were identified using maximum likelihood analysis. Univariate and multivariate analyses using a binary regression logistic model were performed to identify patient, tumor and dosimetric predictors of AE. Results: Grade 2 or 3 AE occurred in 24% and 52% of pts in group 1 and 2, respectively (p < 0.001). For the 93 group 1 pts, the fitted LKB model parameters were: m = 0.15, n = 0.29 and TD50 = 46 Gy. For the 64 group 2 pts, the parameters were: m = 0.42, n = 0.09 and TD 50 = 36 Gy. In multivariate analysis, the only significant predictors of AE were: NTCP (p < 0.001) and V50, as continuous variable (RR = 1.03, p = 0.03) or being more than a threshold value of 11% (RR = 3.6, p = 0.009). Conclusions: A LKB NTCP model has been established to predict AE in a Chinese population, receiving thoracic RT, alone or combined with CT. The parameters of the models appear slightly different than the previous one described in Western countries, with a lower volume effect for Chinese patients. © 2010 Elsevier Ireland Ltd. All rights reserved. Source

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