Journal of Clinical Oncology, Vol 12, 1814-1820, Copyright © 1994 by American Society of Clinical Oncology

ARTICLES

Daily low-dose cisplatin plus concurrent high-dose thoracic irradiation in locally advanced unresectable non-small-cell lung cancer: results of a phase II Southwest Oncology Group study

MB Hazuka, JJ Crowley, PA Bunn Jr, M O'Rourke, TJ Braun and RB Livingston
University of Michigan Medical Center, Ann Arbor.

PURPOSE: This single-arm phase II trial was designed to evaluate the efficacy and toxicity of continuous-course, high-dose thoracic irradiation (RT) combined with concurrent daily low-dose cisplatin followed by high-dose cisplatin consolidation in patients with locally advanced unresectable non-small-cell lung cancer (NSCLC). The daily chemotherapy regimen was designed to optimize the radiosensitizing properties of cisplatin. PATIENTS AND METHODS: Sixty-five patients from 21 participating institutions were entered onto the study between April 1989 and May 1991. Protocol therapy consisted of daily intravenous (i.v.) cisplatin (5 mg/m2) plus concurrent continuous-course RT (61 Gy over 6 1/2 weeks) both delivered Monday through Friday each week. After a 3- to 4-week rest period, this was followed by three 28-day cycles of cisplatin at 100 mg/m2 or subsequently 50 mg/m2 administered i.v. on days 1 and 8 of each cycle. RESULTS: Sixty-four patients were eligible; the majority had unresectable stage IIIa (36%) or IIIb (55%) NSCLC. The remaining 9% had recurrent disease confined to the chest (five patients) or stage II disease (one patient). The feasibility of this regimen is demonstrated by the fact that only five patients (8%) were unable to complete daily cisplatin and RT because of toxicity. Esophagitis (16%), leukopenia (14%), nausea (8%), and vomiting (6%) were the most common severe (grade 3) toxicities. There was only one life-threatening toxicity (grade 4 nausea) and no treatment-related deaths. The objective response rate was 39%, and six patients (9%) achieved a radiographic complete response (CR). The median survival duration for all patients was 14 months, and the 1- and 2-year actuarial survival rates were 56% and 24%, respectively. For stage IIIa patients, the median survival duration and 2-year survival rate were 17 months and 38%, as compared with 10 months and 14% for stage IIIb patients, respectively. CONCLUSION: Daily low-dose cisplatin plus concurrent high-dose continuous-course RT is a well-tolerated out- patient regimen. The survival results are encouraging and appear to be equivalent to more toxic combined approaches. These results warrant further testing of combined daily platinum analogs with RT.
CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				T. Fujii, H. Kunikane, H. Okamoto, K. Watanabe, H. Kunitoh, K. Mori, A. Yokoyama, H. Fukuda, T. Tamura, and N. Saijo A Phase II Study of Cisplatin and Irinotecan as Induction Chemotherapy Followed by Accelerated Hyperfractionated Thoracic Radiotherapy with Daily Low-dose Carboplatin in Unresectable Stage III Non-small Cell Lung Cancer: JCOG 9510 Jpn. J. Clin. Oncol., December 1, 2009; 39(12): 784 - 790. [Abstract] [Full Text] [PDF]