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P.J. Hesketh
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MINI 15 - Chemotherapy Developments for Lung Cancer (ID 128)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:L. Crinò, C.P. Belani
- Coordinates: 9/08/2015, 16:45 - 18:15, Mile High Ballroom 1a-1f
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MINI15.15 - Discussant for MINI15.11, MINI15.12, MINI15.13, MINI15.14 (ID 3547)
16:45 - 18:15 | Author(s): P.J. Hesketh
- Abstract
- Presentation
Abstract not provided
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MINI 17 - WT EGFR, Angiogenesis and OMD (ID 131)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:R. Feld, R. Dziadziuszko
- Coordinates: 9/08/2015, 16:45 - 18:15, Mile High Ballroom 4a-4f
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MINI17.02 - SWOG 0709: Randomized Phase II Trial of Erlotinib vs. Erlotinib plus Carboplatin/Paclitaxel in Patients (Pts) with Advanced Non-Small Cell Lung Cancer (NSCLC) and Impaired Performance Status (PS2) as Selected by Serum Proteomics (ID 658)
16:45 - 18:15 | Author(s): P.J. Hesketh
- Abstract
- Presentation
Background:
Advanced NSCLC pts with Zubrod PS2 are often excluded from clinical trials and platinum-based therapy. In SWOG 0341, erlotinib in PS 2 pts yielded progression-free (PFS) and overall survival (OS) of 2.1 and 5 months respectively. In a trial of erlotinib versus carboplatin/paclitaxel in PS2 pts (Lilenbaum, JCO 2008), PFS for erlotinib and chemotherapy were 1.9 and 3.5 months, respectively. Early reports suggested a potential role for serum proteomics in predicting erlotinib benefit beyond that of EGFR mutational status. We therefore conducted a prospective trial of erlotinib +/- chemotherapy in NSCLC pts with PS2 enriched by serum proteomics (Veristrat assay).
Methods:
Metastatic NSCLC pts with PS2, acceptable end-organ function, and “good” classification by serum proteomics were randomized to either Arm A (erlotinib 150 mg orally QD) or Arm B (erlotinib 150 mg orally QD on days 2-16 plus carboplatin AUC 5 IV day 1 and paclitaxel 200 mg/m2 IV day 1 x 4 cycles, followed by erlotinib 150 mg orally QD). Cycle length was 3 weeks. Arm B agents were “pharmacodynamically separated” to mitigate potential antagonism. The arm with superior observed median PFS would be selected for further evaluation, but only if ≥ 3 months. A sample size of 98 pts was based on a variety of assumed PFS probabilities for each arm. The trial was prematurely closed after the FDA determined midway through accrual that an IDE application was required for the proteomics assay; however SWOG had limited resources available for such filing.
Results:
Of 156 pts screened, 83 (59%) were classified as “good” by serum proteomics. 59 of 83 pts (60%) met trial eligibility and were randomized. Treatment-related grade 4 adverse events were seen in 2 pts in Arm A (thrombosis, hypomagnesemia) and 5 pts in Arm B (neutropenia -5, febrile neutropenia-1, leukopenia -1), with no treatment related deaths. Figure 1
Conclusion:
In Zubrod PS2 pts with advanced NSCLC and “good” classification by serum preoteomics, pharmacodynamically-separated erlotinib plus chemotherapy had better observed median PFS/OS versus erlotinib alone and surpassed the protocol-specified benchmark of PFS >= 3 months required for further study. Updated data will be presented.
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ORAL 29 - MASCC-IASLC Joint Session: Palliative and Supportive Care (ID 136)
- Event: WCLC 2015
- Type: Oral Session
- Track: Palliative and Supportive Care
- Presentations: 1
- Moderators:A. Molasiotis, P. Van Houtte
- Coordinates: 9/08/2015, 16:45 - 18:15, 708+710+712
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ORAL29.03 - Efficacy of the Antiemetic Combination Agent, NEPA, in Patients with Lung Cancer Receiving Platinum Chemotherapy (ID 1275)
16:45 - 18:15 | Author(s): P.J. Hesketh
- Abstract
- Presentation
Background:
Lung cancer is the most common cancer worldwide with first-line chemotherapy treatments consisting predominantly of emetogenic platinum agents. Chemotherapy-induced nausea and vomiting (CINV) can be prevented in most patients with appropriate combination antiemetic regimens. The antiemetic standard-of-care for patients receiving cisplatin consists of a combination of a NK~1~ receptor antagonist (NK~1~RA), a 5-HT~3~ RA, and dexamethasone (DEX). Adherence to antiemetic guidelines is unacceptably low with patients frequently not receiving recommended antiemetic combinations. NEPA has been developed as the first oral antiemetic combination; it delivers guideline-consistent prophylaxis with its combination of a highly selective NK~1~ RA (netupitant [NETU] 300 mg) and the pharmacologically/clinically distinct 5-HT~3~ RA, palonosetron (PALO 0.50 mg). NEPA has demonstrated superior prevention of CINV compared with oral PALO. The intent of this retrospective analysis was to evaluate the efficacy of NEPA in a subset of lung cancer patients from two of the pivotal trials.
Methods:
Patients in two randomized, double-blind trials received a single dose of NEPA on Day 1 prior to cisplatin- or carboplatin-based chemotherapy. Three dose groups (NETU 100/200/300 mg + PALO 0.50 mg) showing similar efficacy were pooled in Study 1, while all patients in Study 2 received NETU 300mg/PALO 0.50 mg. All patients also received oral DEX on Day 1 (carboplatin) or Days 1-4 (cisplatin). Study 1 was single cycle, while Study 2 included evaluation over multiple chemotherapy cycles. The focus of this analysis was on the efficacy of NEPA only, as a PALO comparator group was included in only one of these studies. Endpoints were complete response (CR: no emesis, no rescue) and no significant nausea (max <25 mm on 100 mm visual analog scale) during the acute (0-24h), delayed (25-120h), and overall (0-120h) phases.
Results:
231 patients (78% males, 22% females) with lung cancer received NEPA; 152 patients received cisplatin and 79 received carboplatin as initial chemotherapy. CR rates in Cycle 1 exceeded 90% in Study 1 and 80% in Study 2 (Table). As expected, overall nausea rates were somewhat lower than CR rates (87% Study 1, 80% Study 2). Overall CR rates were maintained over subsequent cycles in Study 2 (87%, 95% and 94% in Cycles 2-4, respectively). Figure 1
Conclusion:
As a combination antiemetic agent targeting two critical pathways associated with emesis, NEPA offers a convenient and highly effective option for prevention of CINV in lung cancer patients receiving platinum-based emetogenic chemotherapy.
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P3.06 - Poster Session/ Screening and Early Detection (ID 220)
- Event: WCLC 2015
- Type: Poster
- Track: Screening and Early Detection
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.06-004 - Update in the Surgical Outcomes in a Large Clinical Low-Dose Computed Tomographic Lung Cancer Screening Program (ID 1529)
09:30 - 17:00 | Author(s): P.J. Hesketh
- Abstract
Background:
Lung Cancer screening with low-dose computed tomography (LDCT) has been shown to reduce lung cancer mortality in high-risk individuals. Critics raise concern over the potential for unnecessary surgical procedures for benign disease as a result of screening. We have up-dated our surgical outsomes in a large clinical lung cancer screening program to assess the number of surgical procedures done for benign disease.
Methods:
We retrospectively reviewed our surgical outcomes of consecutive individuals who underwent LDCT lung cancer screening from January 2012 through March 2015 using a prospectively collected database. All patients met the National Comprehensive Cancer Network (NCCN) Lung Cancer Screening Guidelines high risk criteria.
Results:
There were 2,043 screened individuals during this interval with clinical follow-up at Lahey Hospital and Medical Center. Thirty-nine of the 2.043 (1.9%) had surgery. Twenty-eight (72%) had lung cancer, 25/28 (89%) had early stage and 3/28 (11%) had advanced stage lung cancers. Four (10%) had non-lung cancer malignancies. Seven of thirty-nine (18%) were found to have benign disease. There were no in hospital or 30 day mortalities in those who had surgery and only one (2.56%) major surgical complication.
Conclusion:
The incidence of surgical intervention for non-lung cancer diagnosis was low (0.56%) and is comparable to the rate reported in the National Lung Cancer Screening Tria; (0.62%). Surgical intervention for benign disease was rare (0.34%) in our experience.
