Fukuoka M, Noda K, Hasegawa K, Nakajima H, Furuse K, Hirabayashi K, Hasegawa K, Ogura T, Niitani H, Taguchi T
2nd Dept. of Internal Medicine, Osaka Prefectural Habikino Hospital.
Gan To Kagaku Ryoho. 1996 Nov;23(13):1813-24.
An early phase II cooperative study of Gemcitabine Hydrochloride (abbreviated to "gemcitabine" herewith) was conducted in patients with a variety of solid tumors (i.e., lung cancer, gastric cancer, pancreatic cancer, colon/rectum cancer, cervical cancer, ovarian cancer and breast cancer) at 56 institutions. The aim of the first step (Step I) was to investigate the feasibility of gemcitabine in a variety of different solid tumors, including lung cancer regarding efficacy and safety. The aim of the second step (Step II) was as a result of step I (Responses were observed) to continue to investigate the efficacy and safety of gemcitabine in chemonaive patients with non-small cell lung cancer. As a Step I study, gemcitabine was administered once weekly at a dose of 800 mg/m2 for a consecutive 3-week period followed by a week of rest, in multiple courses. Among the 29 eligible patients with lung cancer, partial response (PR) was achieved in 3 patients (25.0%, 95% confidence interval: 5.5-57.2%) out of 12 chemonaive patients. Adverse reactions (grade 3 or higher) seen in 29 patients with lung cancer were neutropenia (27.6%), leukopenia (13.8%), decreased hemoglobin (13.8%), thrombocytopenia (10.3%), malaise (6.9%), anorexia (3.4%), nausea/vomiting (3.4%), diarrhea (3.4%), dyspnea (3.4%) and interstitial pneumonia (3.4%). In other types of solid tumors, PR was achieved in 2 (8.7%) out of 23 eligible patients with cervical cancer and in 1 (5.3%) of 19 eligible patients with ovarian cancer, while the use of analgesics became unnecessary in 1 patient with pancreatic cancer. Incidence as well as severity of main adverse reactions in these patients were comparable to those seen in patients with lung cancer. A Step II study, in which gemcitabine was administered once weekly at a dose of 1,000 mg/m2 to chemonaive patients with non-small cell lung cancer, was conducted, referring to the results of Step I and clinical studies conducted overseas. The results of the Step II study demonstrated PR in 5 (14.3%, 95% confidence interval: 4.8 - 30.3%) out of 35 eligible patients with non-small cell lung cancer and that the main adverse reactions were comparable to those seen in the Step I study, posing no tolerability problems in particular.
一项关于盐酸吉西他滨（以下简称为“吉西他滨”）的II期早期合作研究在56家机构对患有多种实体瘤（即肺癌、胃癌、胰腺癌、结肠/直肠癌、宫颈癌、卵巢癌和乳腺癌）的患者开展。第一步（第一步）的目的是研究吉西他滨在包括肺癌在内的多种不同实体瘤中的疗效和安全性的可行性。第二步（第二步）的目的是由于第一步（观察到有反应）的结果，继续研究吉西他滨在未经化疗的非小细胞肺癌患者中的疗效和安全性。作为第一步研究，吉西他滨以800mg/m²的剂量每周给药一次，连续3周，随后休息一周，进行多个疗程。在29例符合条件的肺癌患者中，12例未经化疗的患者中有3例（25.0%，95%置信区间：5.5 - 57.2%）达到部分缓解（PR）。29例肺癌患者中出现的3级及以上不良反应有中性粒细胞减少（27.6%）、白细胞减少（13.8%）、血红蛋白降低（13.8%）、血小板减少（10.3%）、不适（6.9%）、厌食（3.4%）、恶心/呕吐（3.4%）、腹泻（3.4%）、呼吸困难（3.4%）和间质性肺炎（3.4%）。在其他类型的实体瘤中，23例符合条件的宫颈癌患者中有2例（8.7%）达到PR，19例符合条件的卵巢癌患者中有1例（5.3%）达到PR，而1例胰腺癌患者不再需要使用镇痛药。这些患者中主要不良反应的发生率和严重程度与肺癌患者所见相当。参考第一步的结果和海外开展的临床研究，对未经化疗的非小细胞肺癌患者开展了第二步研究，其中吉西他滨以1000mg/m²的剂量每周给药一次。第二步研究的结果显示，35例符合条件的非小细胞肺癌患者中有5例（14.3%，95%置信区间：4.8 - 30.3%）达到PR，且主要不良反应与第一步研究所见相当，尤其不存在耐受性问题。
