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P.M. Ellis
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MA09 - Immunotherapy Combinations (ID 390)
- Event: WCLC 2016
- Type: Mini Oral Session
- Track: Chemotherapy/Targeted Therapy/Immunotherapy
- Presentations: 1
- Moderators:M. Sebastian, E.B. Garon
- Coordinates: 12/06/2016, 14:20 - 15:50, Strauss 2
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MA09.03 - Cisplatin/Pemetrexed + Durvalumab +/- Tremelimumab in Pts with Advanced Non-Squamous NSCLC: A CCTG Phase IB Study - IND.226 (ID 5522)
14:32 - 14:38 | Author(s): P.M. Ellis
- Abstract
- Presentation
Background:
Immune checkpoint inhibitors are now established therapies in many advanced cancers. Preliminary studies suggest combining immune checkpoint inhibitors with platinum-based chemotherapy may enhance anti-tumour activity. The primary objective of this multi-centre study was to evaluate the safety and tolerability of durvalumab (Du), a PD-L1 inhibitor, ± tremelimumab (Tr), a CTLA-4 inhibitor, in combination with one of four standard platinum-doublet regimens (pemetrexed (pem), gemcitabine, etoposide (each with cisplatin) or nab-paclitaxel (with carboplatin)), in order to establish a recommended phase II dose (R2PD) for each combination. This abstract focuses on the pem / cisplatin cohort in non-squamous non-small cell lung cancer (NSCLC).
Methods:
Patients (pts) with advanced NSCLC (no prior treatment for advanced disease) who were eligible for treatment with cisplatin and pemetrexed were enrolled into one of four dose levels, regardless of tumour PD-L1 status. Concurrent with chemotherapy, dose level (DL) 0 added Du 15 mg/kg IV q3wks; DL1 added Du 15mg/kg q3wk + Tr 1mg/kg x1 dose; DL2a added Du 15mg/kg q3wk + Tr 1 mg/kg q6wk x multiple doses; DL2b added Du 15mg/kg q3wk + Tr 3 mg/kg q6wk (1 dose with cycle 1 and 2 doses with maintenance pem). Pemetrexed and Du maintenance continued after completion of 4-6 cycles of pemetrexed and cisplatin.
Results:
Twenty-four pts (median age=61 (range 37-78); 50% female, 95% ECOG PS≤1, were enrolled (5 pts to each of DL 0 and 1 and 7 pts each to DL2a and 2b). Thus far 121 cycles have been administered. The majority of drug-related adverse events (AEs) were ≤ grade 2. Most AEs were related to chemotherapy; other AEs were chemotherapy or immune-related (renal, hepatic, skin and pulmonary toxicity). AEs that were considered related to Du or Tr were mainly ≤ grade 2, the most common of which were fatigue (46%), nausea/vomiting (25%), anorexia (21%) and diarrhea (13%). Two pts (DL2a) had serious related AEs (febrile neutropenia related to chemotherapy and lung infection/pneumonitis related to both chemotherapy and Du + T (considered a DLT)). Seventeen of the 24 patients are currently evaluable for response. The provisional objective response rate is 52.9% (95% CI: 28 -77%).
Conclusion:
In this PD-1 unselected patient population, Du 15mg/kg q3w and Tr 1mg/kg (multiple doses q6w) or 3mg/kg (3 doses q6w) can be safely combined with full doses of platinum-doublet chemotherapy. Additional studies with this combination are being planned.
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P1.07 - Poster Session with Presenters Present (ID 459)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: SCLC/Neuroendocrine Tumors
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.07-050 - Patterns of Relapse in Small Cell Lung Cancer (SCLC): A Retrospective Analysis of Outcomes from a Single Canadian Center (ID 5387)
14:30 - 14:30 | Author(s): P.M. Ellis
- Abstract
Background:
We conducted a retrospective review of small cell lung cancer patients (SCLC) to explore patterns of relapse and utility of Prophylactic Cranial Irradiation (PCI).
Methods:
A retrospective chart review was carried on patients diagnosed with SCLC from January 1[st] 2011 until December 31[st] 2014 and treated at Juravinski Cancer Center. The primary outcome was to determine pattern of first relapse. Secondary outcomes were physician assessed response rate, overall survival (OS), utilization of PCI, time to systemic relapse (TTR) and time to central nervous system (CNS) relapse.
Results:
A total of 275 patients were identified, of whom 46 (16.7%) received no chemotherapy (median OS 2.2 months (m)) and were not included in further analyses. The median age of 229 treated patients was 66 (SD 9.3) yrs. There were 115 men, 114 women, 84 (37%) had limited stage (LS) and 145 (63%) extensive stage (ES) disease, performance status (PS) was 0-1 in 133 (58%), PS2 in 66 (28%) and PS3-4 in 32 (13%). Brain metastases were present in 36 (16%) patients at diagnosis. Almost all patients received cisplatin (53%) or carboplatin (43%) plus etoposide chemotherapy. Most patients received 4 (23%), or more (52%) cycles of chemotherapy. Physician assessed RR was 68% (PR 61%, CR 7%) and 16% of patients progressed during first-line therapy. Thoracic radiation (TRT) was given to 112 (49%) of patients (LS 87%, ES 27%). Patients with brain metastases at diagnosis, or progressing during first-line chemotherapy were not considered eligible for PCI. Among 156 eligible patients, 80 (51%) received PCI (LS 64%, ES 39%). Forty-one patients (26.3%) declined PCI. The median overall survival for all patients was 11.1m (LS 21.7m, ES 8.9m). Relapse occurred in 167 (73%) of patients: CNS alone 8.7%, CNS plus systemic relapse (13.1%), thoracic (28%), extra-thoracic (9%), thoracic/extra-thoracic (14%). Median time to any relapse was 9.2m (LS 14.3m, ES 7.5m), while median time to CNS relapse was 6.9m (PCI given 6.2m, PCI not given 4.4m). Among 50 patients with CNS relapse, 16 received PCI (LS 9, ES 7) and 34 did not (LS 8, ES 26). Among 64 patients with thoracic relapse, 31 received TRT (LS 19, ES 12) and 33 did not (LS 5, ES 28).
Conclusion:
Only 50% of eligible SCLC patients receive PCI. CNS relapse occurs frequently and more commonly in patients who do not receive PCI. Implementation of PCI in routine clinical practice appears to influence patterns of recurrence.
