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Phase II study of cisplatin with irinotecan as induction chemotherapy followed by chemoradiotherapy for unresectable stage III non-small cell lung cancer.

AbstractBACKGROUND/AIM:
We evaluated the anti-tumor activity and safety of cisplatin with irinotecan (IP) induction chemotherapy followed by chemoradiotherapy with etoposide/cisplatin (EP).
PATIENTS AND METHODS:
Induction chemotherapy consisted of irinotecan i.v. and cisplatin i.v. and was administered on day 1 and day 8 of each cycle. Patients underwent two cycles of chemotherapy with a 3-week interval. In the absence of progressive disease, 66 Gy radiation was administered concurrently with etoposide on days 1 to 5 and 29 to 33, as well as with cisplatin on day 1, 8, 29, and 36.
RESULTS:
Twenty patients were enrolled between July 2007 and December 2009. This study was closed prematurely due to lack of efficacy in induction chemotherapy. The overall response rate was 45% [95% confidence interval (CI), 25 to 65%], which did not meet the upper limit for first stage rejection of the treatment. The rates of 3-year progression-free survival and overall survival were 17.1% (95% CI, 0 to 36.8%) and 25% (95% CI, 0.2 to 49.8%), respectively. The primary toxicities included neutropenia, diarrhea and fatigue.
CONCLUSION:
This study failed to demonstrate a benefit for induction chemotherapy which was characterized by suboptimal antitumor activity and was poorly tolerated, with excess treatment-related toxicity.
AuthorsHyun Chang, Se Hyun Kim, Byoung Chul Cho, Sang Hyun Yoon, Hye Ryun Kim, Chang Geol Lee, Joo Hang Kim
JournalAnticancer research (Anticancer Res) Vol. 32 Issue 8 Pg. 3515-21 (Aug 2012) ISSN: 1791-7530 [Electronic] Greece
PMID22843939 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Irinotecan
  • Cisplatin
  • Camptothecin
Topics
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
  • Camptothecin (administration & dosage, analogs & derivatives)
  • Carcinoma, Non-Small-Cell Lung (drug therapy, pathology, radiotherapy)
  • Cisplatin (administration & dosage)
  • Combined Modality Therapy
  • Disease Progression
  • Female
  • Humans
  • Irinotecan
  • Lung Neoplasms (drug therapy, pathology, radiotherapy)
  • Male
  • Middle Aged
  • Neoplasm Staging

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