Cisplatin dose intensity in non-small cell lung cancer: Phase II results of a day 1 and day 8 high-dose regimen

David R. Gandara, Howard Wold, Edith A. Perez, Albert B. Deisseroth, J. Doroshow, F. Meyers, K. Mcwhirter, J. Hannigan, Michael W. De Gregorio

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64 Scopus citations


Between October 1985 and March 1987, 92 patients were registered on a phase II study of the Northern California Oncology Group investigating the importance of dose intensity in the treatment of advanced non-small cell lung cancer (NSCLC). Treatment consisted of high-dose cisplatin in hyper-tonic saline (200 mg/m2 on a 28-day cycle) given in a divided day 1 and day 8 schedule. The response rate among 76 assessable patients was 36% (27/76), with complete response (CR) in 8% (6/76) and partial response (PR) in 28% (21/76). If all patients receiving any drug therapy were considered, the overall response rate was 31% (27/87), with CR in 7% (6/87) and PR in 24% (21/87). Median survival times for all assessable patients and all patients receiving any therapy were 37 and 35 weeks, respectively. With the use of a protocol design specifying dose delays rather than dose reduction for toxicity, the mean dose intensity delivered was 47.2 mg/m2 per week, or 94% of projected. Compared with other dose-intensive regimens of cisplatin, this day 1 and day 8 schedule was relatively well tolerated, with peripheral neuropathy as the dose-limiting toxicity. The data on response and median survival times among paptients receiving this singleagent therapy are encouraging. They support the potential importantce of cisplatin dose intensity in the treatment of NSCLC. Whether these results represent a positive dose-response effect in NSCLC will be tested in a randomized comparative trial of high-dose versus standard-dose cisplatiin therpaty.

Original languageEnglish (US)
Pages (from-to)790-794
Number of pages5
JournalJournal of the National Cancer Institute
Issue number10
StatePublished - May 22 1989

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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