A phase II study of pemetrexed and carboplatin in patients with locally advanced or metastatic breast cancer.
Journal - Breast cancer research and treatment (Netherlands )
BACKGROUND: Pemetrexed and carboplatin have demonstrated activity in breast cancer. Their potential synergism in experimental models and the proven efficacy of pemetrexed/platinum in other indications make pemetrexed/carboplatin an attractive combination in breast cancer. Thus, this two-stage, sequential, open-label, multicenter, phase II study assessed the efficacy and safety of pemetrexed plus carboplatin as first-line therapy in patients with locally advanced breast cancer (LABC) or metastatic breast cancer (MBC). PATIENTS AND METHODS: Patients >or= 18 years with a histologic/cytologic diagnosis and no prior chemotherapy for LABC or MBC received pemetrexed 600 mg/m(2) and carboplatin AUC 5.0 on day 1 every 21 days with folic acid and vitamin B(12) supplementation. RESULTS: From June 2003 to April 2005, 50 patients with stage IIIB (30.0%) and stage IV (70.0%) disease were enrolled at 3 study centers. Twenty-eight percent of patients previously received adjuvant chemotherapy, 46.0% had visceral metastases, and 36.0% had >or=3 organs involved. Partial responses (RECIST criteria) were achieved in 27 (54.0%) patients (ORR = 54.0%; 95% CI, 39.3-68.2%). The median response duration was 11.1 months (95% CI, 6.5-14.0 months) and the median time to disease progression was 10.3 months (95% CI, 8.3-14.6 months). CTC hematologic toxicities were grade 3/4 neutropenia (58.0%/28.0%) and grade 3 thrombocytopenia (10.0%) and anemia (18.0%). Two (4.0%) patients had febrile neutropenia, 1 of whom died. No grade 4 non-hematologic toxicities occurred. Grade 3 non-hematologic toxicities were ALT (4.0%) and AST elevation, and edema, fatigue, pruritus, rash/desquamation, and renal toxicity (2.0% each). CONCLUSIONS: Results of this study suggest that the combination of pemetrexed and carboplatin has promising efficacy and an acceptable safety profile. Further assessment of this combination in a randomized trial of various breast cancer patient populations is warranted.
Cisplatin-etoposide and carboplatin-etoposide induction chemotherapy for good-risk patients with germ cell tumor*
Journal - Annals of Oncology
Background: In an attempt to reduce the toxicity of chemotherapyin good-risk testicular cancer patients the two drug combinations,cisplatin plus etoposide (EP) and carboplatin plus etoposide(EC), have been compared.Methods: Good risk was defined according to the MSKCC and IUcriteria. 39 Patients have been treated with EP (cisplatin 20mg/m2 i.v. and etoposide 100 mg/m2 i.v. on days 1 to 5), and23 patients received EC (carboplatin 350 mg/m2 on day 1 andetoposide 100 mg/m2 on days 1 to 5). Four cycles of chemotherapywere given at 21- and 28-day intervals, respectively, with delaysof up to 7 days in istances of leukocyte counts less than 3.0x 109/l or platelet counts less than 100 x 109/l.Results: In the EP group 34 (87%) of 39 patients achieved CR(26 with chemotherapy alone, 8 with additional surgery). Aftera median follow-up of 26 (12–58) months 3 (9%) patientsrelapsed from CR. Currently 38 patients are alive, and 37 (94%)are NED. In the EC group 20 (87%) of 23 patients achieved CR(15 with chemotherapy alone and 5 with additional surgery).After a median follow-up of 45 (26–57) months 6 (30%)patients relapsed from CR. Currently 19 patients are alive and17 (74%) are NED. There was no difference in survival betweenthe two groups (p = 0.13), but in the EC group the relapse ratewas higher (p = 0.052) and the proportion of patients with NEDwas lower (p = 0.03) in comparison with EP. Toxicity in bothgroups was mild and similar, but 3 EP-treated patients presentedhair loss.Conclusions: The study suggests that carboplatin-etoposide combinationtherapy is inferior to cisplatin-etoposide in patients withgood-risk germ cell tumors.
|Keywords : ||chemotherapy • germ cell tumors • good prognosis|