Polyzos Aristides, Tsavaris Nikolas, Kosmas Christos, Polyzos Kostas, Giannopoulos Athanasios, Felekouras Evangelos, Nikiteas Nikolas, Kouraklis Gregory, Griniatsos John, Safioleas Michael, Stamatakos Michael, Pikoulis Emmanuel, Papachristodoulou Antonios, Gogas Helen
Medical Oncology Unit, Laikon General Hospital, Athens University School of Medicine, Athens, Greece.
Anticancer Res. 2006 Sep-Oct;26(5B):3749-53.
The role of docetaxel in combination with cisplatin in the management of gastric cancer resistant to first-line chemotherapy has not yet been defined. This multicenter prospective phase II study evaluated the activity and toxicity of the docetaxel-cisplatin combination in gastric cancer patients, whose tumors were primarily resistant to first-line chemotherapy or had tumor recurrence after chemotherapy. Treatment consisted of docetaxel 70 mg/m2 i.v. followed by cisplatin 70 mg/m2 both administered on day one, every three weeks. Thirty-two patients were enrolled in the study. The median age was 60 years and the median performance status (ECOG) was 1. Six (19%) patients had tumor progression during adjuvant chemotherapy, 19 (59%) had tumor recurrence after primary chemotherapy and 7 (22%) had tumor progressing while on first-line chemotherapy. Twenty (62%) patients had received non-platinum agents as first-line chemotherapy, while the rest had received the so-called "new generation" regimen that contained cisplatin. Among 32 patients evaluable for response, there were 5 (16%) (CI 95%-8%-35%) partial responses, all in patients that had received non-platinum agents as first-line chemotherapy. Stable disease was recorded in 8 (25%) and progressive disease in 19 (59%) patients. The median response duration was 4 (range 3-6) months, the median time to progression was 5 (range 3-6) months, the median survival after second-line chemotherapy was 6 (range 2-24) months and the median survival after first-line chemotherapy was 12 (range 4-36) months. Myelotoxicity was the main toxicity with grade 3-4 neutropenia occurring in 19 (59%) of the patients and febrile neutropenia in 4 (12%) patients. G-CSF support was given to 25 (78%) patients. Grade 3-4 thrombocytopenia was recorded in 4 (12%) patients. In conclusion, the combination of docetaxel plus cisplatin appears to be a moderately effective regimen with acceptable toxicity when G-CSF support is provided. According to our results, it seems that patients, whose tumors were not exposed to cisplatin during first-line chemotherapy, were more likely to respond to this regimen.
多西他赛联合顺铂用于一线化疗耐药的胃癌治疗的作用尚未明确。这项多中心前瞻性II期研究评估了多西他赛 - 顺铂联合方案在胃癌患者中的活性和毒性，这些患者的肿瘤主要对一线化疗耐药或化疗后出现肿瘤复发。治疗方案为多西他赛70mg/m²静脉滴注，随后顺铂70mg/m²，均在第1天给药，每3周重复一次。32例患者入组本研究。中位年龄为60岁，中位体能状态（ECOG）为1。6例（19%）患者在辅助化疗期间出现肿瘤进展，19例（59%）患者在一线化疗后出现肿瘤复发，7例（22%）患者在一线化疗时出现肿瘤进展。20例（62%）患者接受非铂类药物作为一线化疗，其余患者接受含顺铂的所谓“新一代”方案。在32例可评估疗效的患者中，有5例（16%）（95%CI：8%-35%）部分缓解，均为接受非铂类药物作为一线化疗的患者。8例（25%）患者病情稳定，19例（59%）患者病情进展。中位缓解持续时间为4（3 - 6）个月，中位疾病进展时间为5（3 - 6）个月，二线化疗后的中位生存期为6（2 - 24）个月，一线化疗后的中位生存期为12（4 - 36）个月。骨髓毒性是主要毒性，19例（59%）患者出现3 - 4级中性粒细胞减少，4例（12%）患者出现发热性中性粒细胞减少。25例（78%）患者接受了粒细胞集落刺激因子（G-CSF）支持治疗。4例（12%）患者出现3 - 4级血小板减少。总之，当给予G-CSF支持时，多西他赛加顺铂联合方案似乎是一种疗效中等且毒性可接受的方案。根据我们的结果，似乎在一线化疗期间未接触顺铂的患者对该方案更可能有反应。
