Author of

• 10801

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  P1.11 - Poster Session 1 - NSCLC Novel Therapies (ID 208)

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

  • 10848

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    P1.11-048 - A Phase 2 Study of Intravenous Administration of REOLYSIN® (Reovirus Type 3 Dearing) in Combination with Paclitaxel (P) and Carboplatin (C) in Patients with Squamous Cell Carcinoma of the Lung (ID 3356)

    09:30 - 09:30  |  Author(s): M. Coffey
    • Abstract

    Background
    Squamous Cell Carcinoma of the lung (SCCLung) has long been recognized as very difficult to treat, with few agents showing effectiveness. Because the combination of P/C and REOLYSIN was shown to be active in 2 trials in SCC of the head and neck, we elected to test this regimen in this Phase 2 trial in SCCLung.

    Methods
    We conducted a single-arm, open-label phase II study to determine (primary) the Objective Response Rate (ORR) and(secondary) the 6-month Progression-free Survival (PFS) and the Overall Survival (OS) of patients with metastatic or recurrent squamous cell carcinoma of the lung, treated with REOLYSIN in combination with P/C. The study had a two-stage design, with 19 patients in the first stage. The trial would be terminated if 3/19 or fewer patients obtained an objective response. If the trial continued to the second stage, a total of up to 36 patients would be studied. The primary endpoint wouldbe met if patients in both stages had an ORR of at least 35%. Eligible patients had ECOG PS 0–2, adequate organ function, and no prior systemic chemotherapy for their metastatic or recurrent disease. Prior adjuvant chemotherapy or chemo-XRT for treatment of primary disease was allowed, provided it had been ≥ 6 months since the last chemotherapy. Treatment dosages were: paclitaxel 200 mg/m2 IV over 3 hours; carboplatin at a dose of AUC 6 mg/mL minute calculated using standard formula(s)and REOLYSIN 3x1010 TCID50IV over 1 hour daily for 5 days.

    Results
    32 patients entered the study and received at least one dose of study drug. The patient population included 20 males and 12 females, median age was 62 years (range: 37 to 80 years) and all were Caucasian including one Hispanic patient. Of the 32 entered, 25 patients received more than one Cycle of therapy and a total of 125 cycles were administered in that group (per patient mean=5, median=6, range 2-12). The 7 non-evaluable patients received 1 cycle or less. Of the 25 evaluable patients who received more than one cycle, 12 (48%) had a PR, 10(40%) had stable disease (SD), and 3 (12%) had progressive disease (PD) for overall disease control (CR + PR + SD) in 22/25 (88%). Of 21 patients with >6 months follow-up, 7 (33.3%) have PFS of at least 6 months. The most common adverse events (AEs) seen were those expected with P/C---neutropenia 17 (9=Gr 3-4) and thrombocytopenia 15 (5=Gr 3-4) and those expected with REOLYSIN---fever 6 (1=Gr 3) and fatigue 11 (4=Gr 3). The AE profile of P/C therapy did not appear to be significantly altered by the addition of REOLYSIN. The only serious adverse event reported as unexpected and related to study therapy was reversible Gr 2 elevation of creatinine (and increased BUN) which occurred 3 weeks after Cycle 8 in a 65-year-old woman.

    Conclusion
    Combination therapy with paclitaxel/carboplatin/REOLYSIN was well-tolerated in patients with recurrent/metastatic SCClung and the response results justify further studies.