Author of

• 10874

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  P1.13 - Poster Session 1 - SCLC (ID 200)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Medical Oncology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/28/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 10879

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    P1.13-005 - Paclitaxel and Irinotecan in Platinum Refractory or Resistant Small Cell Lung Cancer: a Galician Lung Cancer Group experience. (ID 2340)

    09:30 - 09:30  |  Author(s): G. Huidobro
    • Abstract

    Background
    Patients with Small Cell Lung Cancer (SCLC) whose disease progresses during or shortly after treatment with platinum, have a poor prognosis. Paclitaxel (P) and irinotecan(I) have demonstrated activity both as monotherapy as in combination regimen for this neoplasm. We present preliminary data from our experience in patients with SCLC refractory or resistant to platinum.

    Methods
    We included patients with measurable disease that had progressed during or within six months of first-line chemotherapy based on platinum, with an Eastern Cooperative Oncology Group (ECOG) performance status <2, adequate liver, renal and bone marrow function. They were treated with (P): 75 mg/m2 and (I): 50 mg/m2, both drugs administered on days 1 and 8 of a 21 day cycle. Treatment was maintained until disease progression and/or unacceptable toxicity.

    Results
    We included 24 patients with a mean age of 59.5 years (43-79) and with metastases in two or more locations in 21 of them (87.5%). A median of 4 cycles of treatment was administered and eight patients (33.3%) received six or more cycles. The main reason for discontinuation of chemotherapy was disease progression, observed in 20 patients (83.3%). Partial response was documented in 16 patients (66.6%), stable disease in three (12.5%) and disease progression in five (20.8%). The median survival time was 24,9 weeks and the 1-year survival time was 22%. There have been no treatment-related deaths. The clinical and hematologic toxicities most frequently observed were grade 1 and 2: nausea (n:7; 29,2%), asthenia (n:7; 29,2%), anorexia (n:6; 25%), diarrhea (n:4; 16,6%), anemia (n:16; 66,6%) and neutropenia (n:12; 50%). There was one (4,1%) grade 4 and two (8,3%) grade 3 neutropenia. There were no cases of grade 4 clinical toxicity and there were eight (33,3%) grade 3 : three of diarrhea (12,5%), two hepatic (8,3%) and three of asthenia (12,5%).

    Conclusion
    This (P) and (I) regimen is an effective and well tolerated option for this subgroup of poor prognosis patients with SCLC. We still continue including patients in this protocol, which ensures future communications of the same.

• 12648

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  P3.11 - Poster Session 3 - NSCLC Novel Therapies (ID 211)

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

  • 12669

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    P3.11-021 - Bevacizumab (B) (10 mg/Kg) in combination with Cisplatin (C) and Docetaxel (D) administered every 2 weeks in patients (p) with advanced non-squamous Non-Small Cell Lung Cancer (nsNSCLC): GGCP047/10 study. (ID 1926)

    09:30 - 09:30  |  Author(s): G. Huidobro
    • Abstract

    Background
    B in combination with platinum doublets followed by continuation maintenance with B prolongs survival and delays progression in chemo-naïve pts with advanced nsNSCLC. In a phase II trial C, D and B (15 mg/kg) every 3 weeks followed by B showed a promising efficacy, in terms of progression free survival (PFS) and overall survival (OS), and an acceptable toxicity profile. In addition, a biweekly schedule of D and C in p with metastatic NSCLC as a front-line CT has demonstrated effective antitumor activity with a reduction in hematologic toxicity, comparable to the results of previous studies using 3-week schedule. Taken together, these data suggest that the addition of B to C/D administered every 2 weeks could increase the efficacy and reduce the toxicity associated with the other schedules.

    Methods
    GGCP 047-10 is a multicenter study in chemo- naïve p diagnosed with advanced nsNSCLC. Eligible p also have measurable disease according to RECIST criteria; age ≥18 years; ECOG PS ≤1; adequate hematological, renal and liver function; life expectancy of at least 2 months and signed informed consent. P receive C (50 mg/m2), D (50 mg/m2), and B (10 mg/kg) every 2 weeks for up to 6 cycles, followed by B alone every 2 weeks until disease progression or unacceptable toxicity. PFS is used as the primary efficacy endpoint. Secondary endpoints include safety profile, overall response rate (ORR), disease control rate (DCR) and OS.

    Results
    32 p were enrolled in the study. Median age was 60 years (range 44-72; 28.1% > 65 years); male/female (%): 81/19; ECOG 0/1/2 (%): 28/63/10; adenocarcinoma (%): 84. Median PFS in overall population was 6.4 months (95% CI, 4.2-8.7). Among the 22 p evaluable for response, the ORR was 63.6% and DCR was 95.4%. Most frequent grade 3/4 hematologic toxicity was neutropenia (40.6%) and grade 3/4 nonhematologic toxicities was asthenia (12.5%) followed by mucositis (6.2%) and diarrhea (3.1%). There were no grade 3/4 hemorrhagic events.

    Conclusion
    Treatment with B, C and D plus maintenance B every 2 weeks is effective as front-line treatment of p with advanced nsNSCLC with acceptable toxicity. These data provide further evidence that B may be used in combination with multiple standard, platinum-based doublets in this setting.