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Phase II trial of imatinib maintenance therapy after irinotecan and cisplatin in patients with c-kit positive extensive-stage small cell lung cancer (ES SCLC).

17089 Background: The prognosis for patients (pts) with ES SCLC is poor, with a median survival of 9 mo. This trial was designed to evaluate the efficacy and toxicity of cisplatin plus irinotecan followed by maintenance imatinib (Gleevec) in pts with c-kit positive ES SCLC.


METHODS
Immunohistochemistry for c-kit was performed on paraffin-embedded tissue prior to enrollment. Treatment consisted of irinotecan 65 mg/m2 IV on days 1 and 8 plus cisplatin 60 mg/m2 IV on day 1 repeated every 21 days for 4 cycles. If no evidence of disease progression was identified, Gleevec was given at 400 mg orally BID until disease progression or unacceptable toxicity.


RESULTS
14 pts have been enrolled: median age 61 yrs (range 47-73); 9 men: 5 women; PS 0/1/2 = 3/10/1. 6 pts did not begin Gleevec due to disease progression (4), persistent grade 3 emesis (1), and referral for radiation therapy (1). 8 pts had a PR with cisplatin/irinotecan and received Gleevec. Median number of wks on Gleevec was 6.1 (range 4.6-25.1). Reasons for discontinuation of Gleevec were disease progression (7) and persistent neutropenia (1). Median progression-free survival was 4.7 mo. (range 0.7-16.3) for all pts and 5.5 mo. (range 4.7-16.3) for pts receiving Gleevec. There were no objective responses to Gleevec, but 3 pts (21%) had stable disease for 12, 15 and 25 wks. Median survival was 8.1 mo. (range 3.7-19.6) for all pts and 10.0 mo. (range 7.1-19.6) for those receiving Gleevec. Myelosuppression was mild (grade 1-2 ANC 13%, anemia 76%, platelets 13%) with one pt with grade 3 neutropenia. Non-heme toxicity included grade 1-2 nausea 76%, diarrhea 51% and peripheral edema 75%.


CONCLUSIONS
Gleevec did not appear to maintain disease stability after response to chemotherapy in the majority of pts despite c-kit tumor positivity. Although disease stability with Gleevec was noted in 3 pts (12-25 wks) and therapy was well tolerated, this approach does not appear to warrant further clinical study. Supported by Novartis Pharmaceuticals. No significant financial relationships to disclose.