Erlotinib or erlotinib and gemcitabine do not warrant further investigation in an unselected elderly patient population.

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8071 Background: Pts diagnosed with advanced NSCLC with good performance status typically receive platinum-based chemotherapy; however, no approved maintenance therapy exists. Tremelimumab, a fully human anti-CTLA4 mAb, is associated with durable responses in some pts with metastatic melanoma. Methods: This open-label, randomized, multicenter, phase II clinical trial evaluating efficacy and safety of tremelimumab as maintenance therapy was conducted in pts with locally advanced or metastatic NSCLC with ECOG performance status ≤1. Pts treated with ≥4 cycles of first-line platinum-based therapy resulting in either stable disease (SD) or response per RECIST were eligible and were randomized 3–6 weeks after prior therapy. Pts received 15 mg/kg IV tremelimumab Q90D or BSC until disease progression. Primary endpoint was progression-free survival (PFS) at 3 months. Secondary endpoints included safety, objective response rate, and 1-year survival. Results: Eighty-seven pts received tremelimumab (n=44) or BSC (n=43). Nine (20.9%; 90% CI: 11.4%, 33.7%) pts receiving tremelimumab and 6 (14.3%; 90% CI: 6.4%, 26.3%) pts receiving BSC were progression free at 3 months. Among pts receiving tremelimumab, there were 2 (4.8%) partial responses and 7 (16.6%) SDs, compared with 0 and 6 (14.3%) pts receiving BSC, respectively. Treatment-related adverse events (AEs) were observed in 27 (61.4%) pts receiving tremelimumab and 3 (7.0%) receiving BSC. Nine pts (20.5%) receiving tremelimumab reported grade 3 or 4 AEs compared with 0 patients receiving BSC. The most common grade 3 or 4 AEs attributed to tremelimumab were diarrhea and colitis (n=4, 9.1%). Conclusions: In pts with advanced NSCLC and good performance status receiving platinum-based first-line therapy, single-agent tremelimumab was tolerable, with safety consistent with prior studies. Although PFS analysis did not demonstrate superiority of tremelimumab over BSC, the 4.8% objective response rate seen only in the investigational arm may support future combination studies. Analysis of 1-year survival is forthcoming. [Table: see text]

: Enzastaurin does not improve efficacy when combined with pemetrexed, carboplatin, and bevacizumab. This combination does not warrant further study in NSCLC.

Background The selection of later‐line treatment for older patients with AJCC (version 7) stage IV non–small cell lung cancer (NSCLC) remains controversial. Nanoparticle albumin–bound (nab)‐paclitaxel is approved with carboplatin for the first‐line treatment of patients with NSCLC and subgroup analysis of phase 3 data has suggested superior survival in older patients. Methods The authors conducted a phase 2 study of nab‐paclitaxel in 42 patients aged ≥70 years who had been treated previously with a platinum doublet regimen; patients also could have received a PD‐1 inhibitor. The primary endpoint of the current study was grade 3 to 5 toxicity (according to the National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0]). In addition to response rate, progression‐free survival (PFS), and overall survival (OS), geriatric assessments also were performed before and during treatment, associations between baseline sarcopenia and outcomes were explored, and changes in T lymphocyte p16 before and during treatment were measured. The authors also performed a retrospective subgroup analysis of 19 older patients who were treated with nab‐paclitaxel as part of a larger, randomized, phase 2 study; data were not combined. Results The rate of grade 3 to 5 toxicities was 33.7%. The most common grade 3 to 5 toxicities were decreased white blood cell count (11.9%), neutropenia (9.5%), and fatigue (11.9%). The response rate was 34.2% (2.6% complete response rate and 31.6% partial response rate). The median PFS was 5.2 months and the median OS was 9.3 months. Adverse prognostic factors were common: 42% of patients were frail and 39% of patients were prefrail, whereas 21% had an Eastern Cooperative Oncology Group performance status of 2 and 27% were sarcopenic. Only frailty was found to be predictive of inferior survival. A subgroup analysis of 19 older patients treated with nab‐paclitaxel alone in a prior trial demonstrated a response rate of 15.8%, a PFS of 4.2 months, and an OS of 13.6 months. Conclusions Fit and prefrail older patients with stage IV NSCLC should be considered for treatment with nab‐paclitaxel after disease progression with doublet chemotherapy.

8035^ Background: Pre-clinical data suggests that ENZ and BEV may have complementary effects in inhibiting angiogenesis. This study compared ENZ vs PBO in combination with PEM+CARBO+ BEV. Methods: Pts ≥18 years of age, non-squamous NSCLC, no prior systemic therapy, disease measurable by RECIST, and ECOG PS 0–1 were randomized. Pts received either PBO or 500 mg ENZ daily after loading dose of 375 mg orally, TID, on day 1, cycle 1. Starting on day 8, cycle 1, patients received PEM 500mg/m2, CARBO AUC 6 and BEV 15mg/kg, intravenously, every 21 days. After 4 cycles, pts continued on BEV+ENZ or BEV+PBO. Pts were stratified by ECOG status, disease stage and site with a planned sample size of 90 pts. Primary end point was progression-free survival (PFS). Secondary end points included objective response rate (ORR) and toxicity. Results: Study was terminated after a planned interim analysis for safety and efficacy. From October 2007 to July 2008, 40 pts were enrolled: 20 in each arm. Median age was 60.5 years (range: 44 to 78); M 52.5%, F 47.5%; ECOG PS 0/1 52.5% and 47.5%; stage IIIB/IV 15% and 85%. Baseline characteristics were well matched. The PEM+CARBO+BEV+ENZ arm received a median of 3 cycles of therapy and the PEM+CARBO+BEV+PBO arm 4 cycles. Median PFS was 4.3 mo and 4.2 mo for ENZ and PBO, respectively (unadjusted HR: 0.94, 95% CI [0.39, 2.33]). ORR for ENZ and PBO was 20% and 25%, respectively. Overall, grade 3/4 toxicities were similar in both arms. One patient in ENZ arm experienced a grade 3/4 hemorrhage (vs. none in the PBO arm). Two patients experienced a GI perforation (1 on each arm): 1 resulted in death on the PBO arm. Both patients had a history of diverticulosis. Conclusions: Based upon the results of this interim efficacy analysis, addition of ENZ to PEM+CARBO+BEV will not significantly prolong PFS in patients with stage IIIB/IV NSCLC. This combination does not warrant further study in NSCLC. [Table: see text] ASCO Conflict of Interest Policy and Exceptions In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519–521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2009 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest .

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