A Phase II Study of Weekly Paclitaxel, Cisplatin and Concurrent Radiation Therapy for Locally-Advanced Unresectable Non-Small Cell Lung Cancer: Early Closure due to Lack of Efficacy.
- Author:
Se Hoon PARK
1
;
Mi Kyung KIM
;
Sun Young KYUNG
;
Young Hee LIM
;
Chang Hyeok AN
;
Jeong Woong PARK
;
Seong Hwan JEONG
;
Jae Woong LEE
;
Kyu Chan LEE
;
Eun Kyung CHO
;
Soo Mee BANG
;
Dong Bok SHIN
;
Jae Hoon LEE
Author Information
1. Department of Internal Medicine, Gachon Medical School Gil Medical Center, Incheon, Korea. ekcho@ghil.com
- Publication Type:Original Article
- Keywords:
Non-small cell lung carcinoma;
Paclitaxel;
Cisplatin;
Radiotherapy
- MeSH:
Carcinoma, Non-Small-Cell Lung*;
Cisplatin*;
Consolidation Chemotherapy;
Disease Progression;
Humans;
Incidence;
Neutropenia;
Paclitaxel*;
Pleural Effusion;
Radiotherapy
- From:Cancer Research and Treatment
2004;36(5):293-297
- CountryRepublic of Korea
- Language:English
-
Abstract:
PURPOSE: In this phase II study, the efficacy and safety of weekly paclitaxel concomitant with cisplatin and thoracic radiotherapy (TRT) was evaluated in patients with locally-advanced unresectable non-small cell lung cancer (NSCLC). MATERIALS AND METHODS: Patients with stage III NSCLC (without pleural effusion or cervical lymphadenopathy) received TRT (63 Gy in 35 fractions over 7 weeks) with concurrent weekly cisplatin 20 mg/m2 and paclitaxel 40 mg/m2/week infused over 3 hours. In patients without evidence of disease progression, the administration of a further 2 cycles of consolidation chemotherapy, consisting of paclitaxel 175 mg/m2 and cisplatin 75 mg/m2, were planned after completion of the TRT. RESULTS: Between Feb 2000 and Dec 2002, 20 patients were entered into the study; 13 completed all 7 weeks of treatment (median 7.6 weeks; range 3.3 to 9.4). Seven out of 16 (43.8%) objective responses were observed, with 15 (75%) patients experiencing at least one episode of grade 3/4 toxicity. The main toxicities were moderate to severe neutropenia and gastrointestinal toxicity. CONCLUSION: The unsatisfactory response rate and the high incidence of grade 3/4 hematologic and non-hematologic toxicities, including 7 early discontinuations of treatment and exceeding the study stopping rules, prompted the early closure of the study. In view of the activity observed, the protocol was amended to protracted continuous infusion paclitaxel, cisplatin and concurrent TRT.
