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INTRODUCTION: Treatment of recurrent platinum-resistant ovarian and peritoneal cancers represents a therapeutic challenge. The aim of this Phase III prospective study was to compare the survival benefits, objective response rate, and toxicities among patients treated by weekly paclitaxel with those who underwent three-weekly paclitaxel in recurrent platinum-resistant ovarian and peritoneal cancers. METHOD: Patients with recurrent platinum-resistant ovarian and peritoneal cancer were allocated to receive either weekly paclitaxel (arm 1) at 80 m/m(2) or three-weekly paclitaxel (arm 2) at 175 mg/m(2). RESULTS: Fifty-five patients were enrolled (30 arm 1, 25 arm 2). The mean age was 56.7 years, and the median performance status was 0 (Eastern Cooperative Oncology Group [ECOG]). For arms 1 and 2, the objective response rates were 27% and 16%, the median progression-free survival were 7 and 4.5 months, and the median overall survival were 15.5 and 12.5 months, respectively. Treatments also significantly improved the quality of life. Treatment was associated with mild toxicities, and while neuropathy was slightly higher for weekly paclitaxel over three-weekly paclitaxel, hematological toxicities were significantly lower for the former than the latter. CONCLUSION: Paclitaxel rechallenge showed antitumor activity in recurrent platinum-resistant ovarian and peritoneal cancers. Weekly paclitaxel achieved better results than three-weekly paclitaxel in terms of survival benefits, quality of life, and toxicities.
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BACKGROUND: Despite being chemosensitive, the majority of triple negative breast cancer (TNBC) patients recur. The primary study objectives were to compare disease free survival (DFS), and overall survival (OS) for TNBC after adjuvant chemotherapy, who underwent maintenance metronomic chemotherapy versus no maintenance therapy. METHODS: TNBC patients were eligible for enrolment if they had TNM stages II-III and fit with our inclusion criteria. Patients were assigned to either: group 1, 3 cycles FEC-100 then 3 cycles docetaxel, carboplatin, followed by maintenance metronomic chemotherapy for 1 year; and group 2, 3 cycles FEC-100 then 3 cycles docetaxel. RESULTS: Between November 2008 and December 2014, 158 patients (78 group 1, and 80 group 2) were enrolled. The mean age was 46 years. The median DFS for groups 1,2 were 28 and 24 months, respectively; P value 0.05. The median OS for groups 1,2 were 37 and 29 months, respectively; P values 0.04. Additionally, during the follow-up period, the overall distant metastasis recurrence rates for groups 1,2 were 26% and 37% respectively. Finally, treatment protocol was tolerated well in both groups with mild toxicity profiles. CONCLUSIONS: Extended adjuvant metronomic chemotherapy achieved significant improvement in the survival and was well tolerated.
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PURPOSE: To evaluate overall survival (OS), progression-free survival (PFS), loco-regional recurrence (LRR), and toxicities for early breast-cancer patients with one to three positive axillary lymph nodes, by the addition of radiotherapy to adjuvant chemotherapy. PATIENTS AND METHODS: Patients were eligible for enrollment into the study if they had pathologically proven stages II breast cancer, with one to three positive axillary lymph nodes. Patients were assigned to one of the two groups; Group 1; adjuvant chemotherapy then radiotherapy, and group 2; adjuvant chemotherapy only. RESULTS: Between September 2008 and August 2014, 75 patients were enrolled. Forty patients group 1, and 35 group 2. The 4-year OS for group 1, and two were 77.5 and 71.4%, respectively. The 4-year PFS for group 1 and 2 were 72.5 and 60%, respectively. During the 54 months follow-up period, 11 patients from group 1 had recurrence (three locoregional, seven metastatic, and one both), and 14 patients from group 2 had recurrence (seven locoregional, three metastatic, and four both). The distant metastasis rate was the same in the two groups. However, the metastasis sites were different in the two groups. CONCLUSION: The addition of radiotherapy in stage II breast cancer with one to three positive lymph nodes improved the PFS, and LRR. Radiotherapy improved OS in patients with high-risk features.
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PURPOSE: This phase III trial was de - signed to compare the survival benefit, surgical respectability, and toxicities among patients treated by neoadjuvant chemotherapy followed by radical cystectomy (arm A), with those treated by radical cystectomy (arm B) in the management of stage II, III urinary bladder cancer. PATIENTS AND METHODS: For inclusion, patients should have pathologically proven urothelial carcinoma in urinary bladder, clinical stages from T2N0M0 to T4aN0M0, patient age less than 65 years, and performance state ≤ 2. Additionally, patients should have adequate hematological, renal, and liver functions. Arm A patients underwent 3 cycles of neoadjuvant cisplatin and gemcitabine followed by radical cystectomy, while arm B patients underwent radical cystectomy directly. RESULTS: Thirty patients had been enrolled in each arm between September 2009 and April 2014 in 3 educational institutes in Egypt. The 3 year OS (overall survival) for arm A, and B were 60% and 50% respectively. The median OS for arm A was 36+ months and that for arm B was 32.5 months. The 3 year progression-free survival (PFS) for arm A, and B were 57% and 43% respectively. The median PFS for arm A was 36+ months and for arm B was 28 months. A subgroup analysis was performed to correlate between 3 year OS and predetermined prognostic factors including age, tumor size, pathological stage, and the response to neoadjuvant chemotherapy. The later was performed only in arm A. Both treatment arms were tolerated well with mild toxicities profiles. CONCLUSION: Neoadjuvant chemotherapy achieved better survival, surgical respectability, with nearly equivalent toxicities when compared with radical cystectomy.
