Author of

• 12727

  +

  P3.13 - Poster Session 3 - SCLC (ID 202)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Medical Oncology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/30/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 12733

    +

    P3.13-006 - Docetaxel-Carboplatin (DC) as Second Line Treatment in Patients With Small Cell Lung Cancer (SCLC): A phase II study. (ID 1877)

    09:30 - 09:30  |  Author(s): F.M.N.H. Schramel
    • Abstract

    Background
    Patients with relapsing SCLC have a poor prognosis and options for treatment are limited. Paclitaxel in combination with platinum has demonstrated activity in first and second-line treatment. We conducted a phase II study to investigate the anti-tumor activity and safety profile of Docetaxel/Carboplatin (DC) in patients with refractory or relapsing SCLC.

    Methods
    SCLC patients who were refractory to or relapsed after first-line treatment and who did not receive platinum based chemotherapy within the 3 months before inclusion, were treated with Docetaxel (75 mg/m[2], day 1 iv) followed by Carboplatin (area under the curve 6, day 1 iv.) once every 3 weeks for 4-6 cycles. Primary endpoint was response rate (RR) and secondary endpoints were time to progression (TTP), overall survival (OS) and safety profile. Tumor response was measured according to RECIST version 1.1. Toxicity was evaluated according to Common Toxicity Criteria of the National Cancer Institute.

    Results
    50 patients (29 male and 21 female) were included with a median (range) age of 67 years (46-82). The majority of patients had an Eastern Cooperative Oncology Group performance status of 1; median time off first-line treatment was 12 weeks. Average number of treatment cycles was 4 (range 1-6). Evaluable for response and toxicity were 45 and 48 patients, respectively. A complete response was achieved in 1 patient, a partial response in 24 patients, stable disease in 16 patients, and progressive disease in 4 patients (RR 73.5%; 95% confidence interval, 59 to 88). Median time to progression was 133 days (range 89-177). Median overall survival was 198 days (range 77-322). One-year survival rate was 34%. Hematologic toxicity grade 3 and 4 was leukopenia 19% and 8%, thrombocytopenia 10% and 2%, and anemia 4% and 0%, respectively, in a total of 186 cycles. Nonhematologic toxicity was diarrhea grade 3-4 (15%), stomatitis grade 3 (4%) and hyponatriemia grade 3 and 4 in one patient each. Seven patients were hospitalized due to neutropenic fever; no toxic deaths occurred.

    Conclusion
    Second-line DC in refractory or relapsing SCLC patients yielded a high RR and toxicity was relatively mild in these poor-prognosis patients. NCT00686985