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20. Dose-finding study of irinotecan and cisplatin plus concurrent radiotherapy for unresectable stage III non-small-cell lung cancer [seecomments]

Author

Yokoyama, A., Kurita, Y., Saijo, N., Tamura, T., Noda, K., Shimokata, K., and Matsuda, T.

Subjects
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Humans, neoplasms, Research Article
Abstract

Irinotecan hydrochloride (CPT-11) shows marked anti-tumour activity alone and in combination with cisplatin in non-small-cell lung cancer (NSCLC). It is necessary to investigate combined-modality therapy including novel effective anti-cancer agents to improve long-term survival of patients with unresectable stage III NSCLC. A phase I/II study of concurrent chemoradiotherapy with CPT-11 and cisplatin was conducted to determine the maximum tolerated dose (MTD) and efficacy in this group of patients. Thirteen previously untreated patients with unresectable stage IIIA/B NSCLC were enrolled and efficacy and toxicity was evaluated in 12 of them; one patient was ineligible. Chemotherapy was repeated every 4 weeks for three courses. Radiation therapy was started on day 2 of the first course of chemotherapy and 60 Gy in 30 fractions was given over 6 weeks. Four of six patients enrolled at level 1 completed the scheduled treatment. Another two received only one and two courses of chemotherapy as a result of persistent leucopenia and neutropenic fever respectively. Three of six patients given level 2 therapy completed the scheduled treatment. Another three received only one and two courses of chemotherapy, two refused treatment because of diarrhoea and one died of pneumonia. Radiation therapy was inadequate in these three patients. As the CPT-11 dose intensity in this trial was low, because of the necessity of omitting CPT-11 administration on days 8 and/or 15 as a result of leucopenia or diarrhoea, and the low radiation therapy completion rate, the trial was discontinued at level 2. Five patients at level 1 and three at level 2 showed partial responses, an overall response rate of 67%. Although neither MTD nor dose-limiting toxicity could be identified, chemotherapy with CPT-11 and cisplatin plus concurrent radiation therapy was deemed unacceptable. We are now conducting a phase I/II study of chemotherapy using CPT-11 as a single agent in combination with radiation therapy.

Published
1998

28. Prognostic value of pleural effusion in patients with non-small cell lung cancer

Author

Sugiura S, Ando Y, Minami H, Ando M, Sakai S, and Shimokata K

Subjects
Adult, Aged, 80 and over, Male, Lung Neoplasms, Middle Aged, Prognosis, Survival Analysis, Pleural Effusion, Carcinoma, Non-Small-Cell Lung, Multivariate Analysis, Humans, Female, Aged, Neoplasm Staging
Abstract

This study was performed to determine whether pleural effusion in patients with advanced non-small cell lung cancer (NSCLC) has a negative impact on survival. We evaluated 12 prognostic factors in 197 patients with stage IIIB or IV NSCLC. Each factor was dichotomized, and survival curves calculated by the Kaplan-Meier technique were compared using the log-rank test. The Cox proportional hazards regression model was used to confirm the significance of each prognostic factor selected by univariate analysis. We compared the survival times for stage IIIB with pleural effusion with those of stage IIIB without effusion and stage IV. To determine the impact of the cytological results of the effusion on survival, we compared the survival times for cytologically positive and negative effusions. Univariate analysis identified eight significant prognostic factors: pleural effusion, node status, stage, performance status, weight loss, hemoglobin, albumin, and lactate dehydrogenase. Pleural effusion was selected as a prognostic factor in the multivariate analysis, together with stage, performance status, albumin, and node status. Median survival times for stage IIIB without effusion, stage IIIB with effusion, and stage IV were 15.3, 7.5, and 5.5 months, respectively (P0.0001). Survival time for stage IIIB with effusion was significantly different from that of stage IIIB without effusion (P = 0.0129) but not from that of stage IV (P = 0.0797). Among patients with effusion, no significant difference in survival time was observed between cytologically positive and negative effusions. We conclude that pleural effusion in advanced NSCLC is a prognostic factor. Survival time for stage IIIB with pleural effusion is more similar to that of stage IV rather than that of stage IIIB without effusion.

Published
1997

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