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P1.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 206)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
P1.01-068 - Randomized Trial of Maintenance Chemotherapy Versus SBRT plus Maintenance Chemotherapy for Advanced NSCLC - Feasibility and Early Outcomes (ID 932)
09:30 - 17:00 | Author(s): G. Raja
Following first-line chemotherapy, maintenance therapy regimens have shown modest yet statistically significant benefits in progression free survival (PFS). To date, there have been no completed, prospective randomized trials examining the role of locally aggressive therapy in limited metastastic, advanced stage non-small cell lung cancer (NSCLC). We hypothesized that stereotactic body radiotherapy (SBRT) prior to maintenance chemotherapy would further improve PFS. This trial also serves to provide prospective survival data for a population with limited metastatic NSCLC.
This is a two-arm randomized phase II trial. Eligible patients have stable disease or partial response with limited metastatic disease (defined by six or fewer sites amenable to SBRT) after treatment with up to 6 cycles of first line platinum doublet chemotherapy. Patients are then randomized to investigator’s choice maintenance chemotherapy alone or SBRT to all amenable sites followed by maintenance chemotherapy. The primary endpoint of the study is PFS, with 36 patients required to demonstrate an increase from 4 months in the control arm to 10 months in the experimental arm, with 80% statistical power and a 2-sided significance level of 0.10.
Since May 2014, 11 patients have been enrolled (5 to SBRT + maintenance arm; 6 to maintenance arm). The median number of first-line chemotherapy cycles was four, with the most common regimen carboplatin/paclitaxel followed by carboplatin/pemetrexed. The median number of maintenance chemotherapy cycles was six, the most common agent being pemetrexed followed by bevacizumab. The median number of sites treated with SBRT were two, with the lung the most common anatomic location followed by the adrenal gland. Five patients have progressed to date, three in the maintenance chemotherapy arm and two in the SBRT + maintenance chemotherapy arm. Progression in the maintenance alone arm occurred in original sites of disease in two of three patients. There have been no in-field failures in the SBRT arm. There has been one death due to disease progression in the maintenance chemotherapy arm. No patients have suffered a grade 3 or higher adverse event related to protocol therapy.
This study demonstrates the feasibility of enrolling patients with limited metastatic lung cancer to a randomized trial of local therapy following first-line chemotherapy. To date, all patients have tolerated the administration of SBRT to multiple sites in between first-line and maintenance chemotherapy without any grade 3 or higher adverse events. Continued follow-up will be necessary to determine the efficacy of the experimental arm.
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