De Giorgi Ugo, Rosti Giovanni, Papiani Giorgio, Aieta Michele, Fochessati Francesca, Paoluzzi Luca, Valduga Francesco, Marangolo Maurizio
Department of Oncology, Ospedale Santa Maria delle Croci, Ravenna, Italy.
Am J Clin Oncol. 2004 Oct;27(5):457-60. doi: 10.1097/01.coc.0000128727.40450.9e.
Although the overall cure rate for advanced germ cell tumor (GCT) is high, the prognosis for patients with cisplatin-refractory GCT remains poor. Gemcitabine, paclitaxel, and oxaliplatin have shown significant activity as single agents in these patients. We investigated the activity and tolerance of a weekly gemcitabine, paclitaxel, oxaliplatin chemotherapy regimen. From September 2000 to February 2002, 9 patients with cisplatin-refractory GCT were treated with gemcitabine 800 mg/m2, paclitaxel 70 mg/m2, and oxaliplatin 50 mg/m2, days 1, 8, and 15, every 4 weeks. Only 1 patient stayed on schedule. In 7 patients, chemotherapy treatment was modified due to grade 3-4 hematological toxicity, whereas in another patient, who received high-dose chemotherapy 2 months before, chemotherapy was administered biweekly. In total, 21 cycles were administered with a median of 2 cycles for each patient. One patient achieved a partial remission lasting 5 months, 1 had disease stabilization for 5 months, whereas 7 had progressive disease. This chemotherapy regimen was not feasible in our patient population. Recently, oxaliplatin at full doses, but not as weekly administration, has appeared to possess activity in cisplatin-refractory GCT. Thus, we plan a phase II study protocol of the oxaliplatin and gemcitabine combination at full doses every 3 weeks.
尽管晚期生殖细胞肿瘤(GCT)的总体治愈率较高,但顺铂难治性GCT患者的预后仍然较差。吉西他滨、紫杉醇和奥沙利铂作为单药在这些患者中已显示出显著活性。我们研究了每周一次的吉西他滨、紫杉醇、奥沙利铂化疗方案的活性和耐受性。2000年9月至2002年2月,9例顺铂难治性GCT患者接受吉西他滨800mg/m²、紫杉醇70mg/m²和奥沙利铂50mg/m²治疗,于第1、8和15天给药,每4周重复一次。只有1例患者按计划进行治疗。7例患者因3-4级血液学毒性而调整化疗方案,而另1例患者在2个月前接受了高剂量化疗,化疗改为每两周进行一次。总共进行了21个周期,每位患者的中位周期数为2个。1例患者达到部分缓解,持续5个月,1例病情稳定5个月,而7例病情进展。该化疗方案在我们的患者群体中不可行。最近,全剂量的奥沙利铂(但不是每周给药)似乎对顺铂难治性GCT具有活性。因此,我们计划开展一项每3周一次的全剂量奥沙利铂与吉西他滨联合的II期研究方案。