Annual Meeting Proceedings Part 1 - American Society of Clinical ...

Lung Cancer—Non-small Cell Local-Regional/Small Cell/Other Thoracic Cancers
TPS7112 General Poster Session (Board #43G), Sat, 1:15 PM-5:15 PM
IFCT-GFPC-0701 MAPS trial, a multicenter randomized phase III trial of
pemetrexed-cisplatin with or without bevacizumab in patients with malignant
pleural mesothelioma (MPM). Presenting Author: Gerard Zalcman,
Caen University Hospital, Caen, France
Background: MPM median OS does not exceed 13 months with pem/CDDP
doublet. U.S. Intergroup phase II trial of gemcitabine/CDDP, with or
without bevacizumab, gave an appealing 15.6 months median OS in the
bevacizumab arm. French Intergroup aimed to test pem/CDDP with
bevacizumab (PCB), in a randomized phase III trial. Methods: Eligible
patients had unresectable histologically proved MPM, no prior chemo, PS
0-2, no thrombosis, nor bleeding. Primary endpoint: The primary outcome
will be survival. The secondary endpoint will be Progression-Free Survival.
Patients received pem 500 mg/m2 , CDDP 75 mg/m2 (PC),at D1, and
vitamin B12 �B9 substitution, with (arm B) or without bevacizumab (arm
A), 15 mg/kg Q21D, for 6 cycles. Arm B nonprogressive patients received
bevacizumab maintenance therapy until progression or toxicity. 445
patients to be recruited during a period 48 months, with at least 24 months
of follow-up, and 385 events (deaths), will be needed to assure a power of
80% and detect at least a 4.3 months of median survival increase. This
hypothesis leads to a Hazard Ratio (HR) of 1.33 and a 3-years survival of
14.7% in control arm and 23.6 % in experimental arm, with an absolute
difference of 8.9% in survival rates. Accrual status: The first patient was
included in February 2008. On January 31, 2012, 257 patients from 85
French centers had been enrolled. The end of accrual can be expected for
September 2013. Ancillary studies: For molecular biomarker analyses,
thoracoscopic tissue specimens (TS, ERCC1, MSH2, TUBB3, NF2, p16,
RASSF1A methylation,15 microRNAs ) and blood samples (micro-RNAS,
VEGF, osteopontin, SRMP) at diagnosis are centrally collected. Finally, a
prospective study comparing PET-CT to standard CT with central blinded
analysis, is currently on-going for evaluation of response, and accuracy of
modified RECIST criteria for mesothelioma.
479s
TPS7113 General Poster Session (Board #43H), Sat, 1:15 PM-5:15 PM
CA184-156: A randomized, multicenter, double-blind, phase III trial
comparing the efficacy of ipilimumab (Ipi) plus etoposide/platinum (EP)
versus EP in subjects with newly diagnosed extensive-stage disease small
cell lung cancer (ED-SCLC). Presenting Author: David R. Spigel, Sarah
Cannon Research Institute, Nashville, TN
Background: EP (4-6 cycles) is standard of care 1st-line therapy for
metastatic SCLC, and no multinational studies have reported any improvement
beyond that reported for EP. Evidence of an ongoing immune
response to SCLC tumors suggests that immunotherapy that enhances this
immune response to SCLC may enhance the clinical benefit of EP. Ipi, a
fully human monoclonal antibody which blocks CTLA-4, augments antitumor
immune responses. Because some responses to Ipi may differ from
those observed with cytotoxic therapies, immune-related response criteria
(irRC) were derived from WHO criteria to better capture response patterns
observed with Ipi. A randomized Phase 2 study of Ipi with paclitaxel/
carboplatin (PC) in pts with ED-SCLC showed significant improvement in
progression-free survival (PFS), as measured by irRC, over PC alone in pts
receiving Ipi and PC in a phased regimen (Ipi started after 2 cycles of PC).
Furthermore, addition of Ipi did not exacerbate PC toxicity, and immunerelated
adverse events were managed using protocol-specific guidelines.
This multicenter phase III study in pts with ED-SCLC (ClinicalTrials.gov
identifier NCT01450761) will determine whether adding Ipi to EP increases
OS vs EP alone. Methods: EP consists of 4 cycles of etoposide (100
mg/m2 , IV on Days 1-3 every 3 weeks [Q3W]) and cisplatin (75 mg/m2 , IV)
or carboplatin (AUC�5, IV) once Q3W. Pts will be randomized to receive 4
doses of Ipi (10 mg/kg, IV) in Arm A or placebo in Arm B, Q3W during
induction, starting after 2 cycles of EP (phased schedule). Eligible pts will
then receive blinded study drug (Ipi in Arm A; placebo in Arm B) Q12W
until disease progression or unacceptable toxicity. The primary objective is
to compare OS. Secondary objectives are to compare OS in those who
receive blinded study drug, compare PFS between study arms, and to
estimate best overall response rate and duration of response. First-line
ED-SCLC pts with ECOG performance �1 will be included. Pts with
symptomatic CNS metastases or a history of autoimmune disease will be
excluded. The study will randomize 1100 pts at a 1:1 ratio.
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