Oscar Fernández-Hidalgo

Docetaxel Plus Vinorelbine as Salvage Chemotherapy in Advanced Breast Cancer: A Phase II Study

AbstractPrécis Administration of a combined regimen of docetaxel plus vinorelbine every 4 weeks is feasible and shows activity in heavily pretreated patients with advanced breast cancer. Purpose. To determine the activity and tolerance of docetaxel plus vinorelbine in heavily pretreated patients with advanced breast cancer. Methods. Thirty-five metastatic breast cancer patients with ECOG performance status of 0–2 received docetaxel (80 mg/m2 given intravenously) on day 1 and vinorelbine (30 mg/m2 given intravenously) on days 1 and 14, every 4 weeks. The median number of prior chemotherapy regimens was 2 (range: 1–4). Twenty-five patients (71.4%) had been treated previously using intensive therapy approaches with peripheral blood-derived stem cell (PBSC) support, including high-dose chemotherapy (11 patients), multicyclic dose-intensive chemotherapy supported with repeated PBSC infusions (seven patients), or both (seven patients). Twenty-eight patients (80%) received previous chemotherapy for metastatic disease. Adjuvant therapy in the remaining seven patients consisted of high-dose chemotherapy and PBSC support or an anthracycline-containing regimen. Results. The total number of courses was 229, and the median number of courses per patient was 6 (range: 1–16). There was one toxic death (2.8%). Grade 3–4 toxicities included mucositis (17.1%), neutropenia (37.1%), anemia (5.7%), vomiting (2.9%), and asthenia (14.3%). Eighteen patients (58%; 95% CI: 40.6–75.4%) achieved an objective response, including four complete responses (12.9%) and 14 partial responses (45.1%). Overall response rate was 51.4% (95% CI: 34.8–67.9%). After a median follow-up of 20 months (range: 2–42), overall survival was 20 months (95% CI: 16–24), and median time to progression was 13 months (95% CI: 7–19). Conclusion. This combination shows activity and an acceptable toxicity profile in patients with advanced breast cancer.

Combined irinotecan, oxaliplatin and 5-fluorouracil in patients with advanced colorectal cancer. a feasibility pilot study.

Objectives: To evaluate the feasibility and a possible activity range of combination irinotecan (CPT-11), oxaliplatin, and 5-FU in advanced colorectal cancer (ACC). Patients and Methods: A total of 53 patients (51% chemoresistant) were treated. Twenty-eight received monthly intravenous oxaliplatin (120 mg/m2) and CPT-11 (250 mg/m2) on day 1 and a course of 5-FU; these constituted the IRI250 group. Twenty-five received monthly intravenous oxaliplatin (120 mg/m2), CPT-11 (300 mg/m2) on day 1, and a course of 5-FU (IRI300 group). 5-FU administration was carried out as follows. Those with predominant hepatic disease (n = 32) received an intra-arterial infusion of 5-FU (2,500 mg/day on days 1–4); these were the IA-FU group. The remaining 21 patients received intravenous 5-FU (2,600 mg/m2 plus leucovorin 500 mg/m2 on days 1 and 15); these constituted the IV-FUFOL group. Results: Intention-to-treat response rate was 54.7% (4 CR, 7.5%). Twelve patients (22.5%) had stable disease; only 4 (7.5%) progressed. Median progression-free and overall survivals were 10 and 18 months, respectively. One-year progression-free and overall survival rates were 44.3 and 67.4%, respectively. Grade 3–4 toxicities included diarrhea (45.3% of patients), neutropenia (52.8%), mucositis (13.2%), and emesis (11.3%). There were 3 treatment-related deaths (5.7%), all in the IA-FU/IRI300 subgroup. Severe adverse effects requiring chemotherapy dose adjustment were observed in 67.9% of the patients, with odds ratios 9.04-fold higher in the IA-FU/IRI300 group (95% CI: 1.07–76.20) and 0.23-fold lower in the IV-FUFOL/IRI250 group (95% CI: 0.05–0.97). Conclusion: This combination seems to have substantial activity in ACC. Overall toxicity was unacceptable in the IA-FU and IRI300 groups, with diarrhea and cytopenia constituting the dose-limiting side effects. Tolerance and efficacy profiles achieved with IV oxaliplatin (120 mg/m2 day 1), IV CPT-11 (250 mg/m2 day 1) and IV 5-FU 2.6 g/m2 with IV leucovorin (500 mg/m2 days 1 and 15) was favorable and deserves further investigation.

Early breast cancer treated with conservative surgery, adjuvant chemotherapy, and delayed accelerated partial breast irradiation with high-dose-rate brachytherapy

PURPOSE To evaluate the feasibility and intermediate-term results of conservative surgery, adjuvant chemotherapy, and delayed accelerated partial breast irradiation (APBI) with high-dose-rate brachytherapy. METHODS AND MATERIALS Between 2000 and 2007, a total of 26 patients with a median age of 54 years were treated with conservative surgery followed by adjuvant chemotherapy and exclusive high-dose-rate brachytherapy. Inclusion criteria followed the Radiation Therapy Oncology Group 95-17 trial guidelines. The tumor bed was marked at the time of surgery (n = 2) or before brachytherapy (n = 24). The brachytherapy procedure was performed at a median of 22 weeks after surgery. A median of 14 brachytherapy catheters were placed in three to four parallel planes. A dose of 34.0 Gy in 10 b.i.d. fractions given over 5 consecutive days was prescribed to the clinical target volume (CTV90). RESULTS After a median followup of 53 months (range, 6.8-81), Radiation Therapy Oncology Group Grade 1-2 events and Grade 3 events were observed in 10 (38.4%) patients and 3 (11.5%) patients, respectively. No Grade 4-5 events were observed. Patients rated their cosmetic result as excellent (37.5%), good (50.0%), fair (8%), or poor (4%) based on the Wazers Criteria. The 6-year actuarial local, elsewhere in the breast, and distant control rates were 100%, 96.2%, and 96.2%, respectively. Six-year disease-free survival and overall survival were 92.3% and 96.2%, respectively. CONCLUSIONS Patients undergoing surgery and adjuvant chemotherapy can still be candidates for APBI. Optimal visualization of the internal lumpectomy scar before implantation is mandatory. Cosmetic results may be slightly worse due to the interaction between chemotherapy and APBI, and technical refinements may be needed in this group of patients.

Pegylated liposomal doxorubicin (PLD) and gemcitabine in the treatment of metastatic breast cancer: A single-institution experience.

e11510 Background: We retrospectively analyzed the efficacy and safety of the combination of PLD and gemcitabine in patients (pt) with metastatic breast cancer (MBC) treated in our institution. Methods: We identified in our database 51 women diagnosed of MBC and treated with PLD on day 1 plus gemcitabine days 1 and 8 every 21 days between July 2000 and August 2009. Results: Median age was 59 years (range 32-83). Histologically 82.4% were ductal carcinomas, 68.6% expressed estrogen receptor and 29.4% overexpressed HER2. The median of previous chemotherapy regimens was 2 (range 0-8). 78.4% pt received previous anthracyclines, 82.4% taxanes, 54.9% capecitabine and 16.7% trastuzumab. 2 pt had previously received PLD and 3 gemcitabine. Median number of metastatic sites was 3 and the most frequent sites were: bone 70.6%, liver 56.9%, lung 37.3% and lymphatics 25.5%. Median PLD dose was 25mg/m2 (range 15-45 mg) and median gemcitabine dose was 800mg/m2 (range 650-1,000 mg). Median number of cycles was 8 (CI95%: 1...