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Best abstracts selected from submissions 5 (ID 6)
- Event: ACLC 2018
- Type: Oral Session
- Presentations: 1
- Coordinates: 11/09/2018, 16:20 - 17:00, Crystal Ballroom 1
OA10 - CheckMate 078: Patient-Reported Outcomes (PROs) With Nivolumab vs Docetaxel in Advanced Non-Small Cell Lung Cancer (NSCLC) (ID 150)
16:20 - 17:00 | Author(s): J. Wang
Nivolumab is approved in China for treatment of previously treated advanced NSCLC without EGFR/ALK alterations based on the findings of CheckMate 078 (NCT02613507), a randomized, open-label phase 3 study in a predominantly Chinese population that demonstrated superior overall survival with nivolumab versus docetaxel. Patients were randomized 2:1 to receive nivolumab 3 mg/kg Q2W or docetaxel 75 mg/m2 Q3W until disease progression or unacceptable toxicity. The results mirrored previous findings in the similar CheckMate 017/057 studies, which included few Asian patients. PROs in CheckMate 017/057 showed reductions in disease-related symptom burden and improvement in health-related quality of life (HRQOL). This study investigated whether similar improvements occurred in CheckMate 078.
Symptom burden was assessed using the Lung Cancer Symptom Scale (LCSS) average symptom burden index (ASBI). HRQOL was assessed using the LCSS 3-item global index (3-IGI) and EQ-5D-3L utility index (UI) and visual analog scale (VAS). Assessments for nivolumab and docetaxel occurred at baseline and every 4 and 3 weeks, respectively, up to week 24, and thereafter every 6 weeks for both treatments.
Of 504 randomized patients, 458 (91%) had evaluable PROs with baseline assessment and ?1 post-baseline assessment (90.4% were Asian and 60.0% had non-squamous tumor histology). Compliance was ?83% for all on-treatment PRO assessments. Ten or more patients remained on nivolumab and docetaxel until week 72 and 30, respectively. Time to first deterioration (TTD) was significantly prolonged with nivolumab vs docetaxel for all PRO measures; hazard ratios (95% confidence interval) were 0.47 (0.35?0.64) for LCSS-ASBI, 0.62 (0.47?0.83) for LCSS-3-IGI, and 0.56 (0.44?0.71) for both EQ-5D-3L VAS and UI. Deterioration rates at week 12 were significantly lower with nivolumab (LCSS, n=313; EQ-5D-3L, n=312) than docetaxel (LCSS, n=137; EQ-5D-3L, n=142) for LCSS-ASBI (31.6% vs 46.7%), EQ-5D-3L VAS (46.8% vs 58.5%), and EQ-5D-3L UI (36.5% vs 51.4%). Patients treated with nivolumab demonstrated clinically meaningful improvements for most LCSS-ASBI assessments after week 30 and all LCSS-3-IGI assessments after week 16; no clinically meaningful improvements were observed with docetaxel (descriptive). HRQOL improvements with nivolumab were observed with the EQ-5D-3L UI (weeks 20?72) and VAS (weeks 16?54), but most were not clinically meaningful.
HRQOL and symptom burden improved with nivolumab vs docetaxel in CheckMate 078. Deterioration rates up to week 12 decreased and TTD was delayed with nivolumab vs docetaxel. Patients treated with nivolumab showed clinically meaningful improvement in symptom burden from baseline. These findings are consistent with those from CheckMate 017/057.
Poster Session (ID 8)
- Event: ACLC 2018
- Type: Poster Session
- Presentations: 1
- Coordinates: 11/07/2018, 00:00 - 00:00, Poster Hall
P036 - Rechallenge Pemetrexed-Based Chemotherapy Provides an (ID 86)
00:00 - 00:00 | Author(s): J. Wang
In clinical practice, various treatments for advanced non-small-cell lung cancer (NSCLC) have been developed, aiming to alleviate the symptoms, prolong the survival and improve the life quality.Due to the absence of a standard multi-line treatment in advanced NSCLC, we hypothesized efficacy from rechallenge with pemetrexed alone or in combination with platinum or taxane for patients previously treated with pemetrexed. This article mainly observed the clinical efficacy and safety of rechallenge pemetrexed-based chemotherapy in locally advanced or metastatic NSCLC patients who had achieved first-line pemetrexed related benefitial response.
This retrospective study captured clinical data from 34 eligible pemetrexed rechallenge patients with advanced NSCLC who received benefitial response with first-line pemetrexed-platinum chemotherapy between January 2012 and December 2017.The progress time and safety of the disease were mainly observed.
With a median follow-up of 30.8 months,the DCR rate were 82.4%,with PR in 4 (11.8%) and SD in 24 (70.6%).Median rechallenge progression free survival(PFS) was 9.35 months, range from 0.9 to 44.2 months. Median overall survival (OS) was 42.2 months, range from 15.3 to 87.1 months.Patients with initial PFS (PFS1) of ?10 months had a longer rechallenge PFS compared to those with a PFS1 of <10 months (median PFS: 9.23 vs. 3.40 months;P=0.047).The significant prognostic factors for prolonging PFS after pemetrexed rechallenge are PFS1 (?10 vs <10 months,HR,0.383;95% CI,0.153-0.960;P=0.041) and line of rechallenge (2nd/3rd vs ?4th,HR,0.358;95% CI,0.145-0.880;P=0.025).It is noteworthy that maintenance treatment(HR,5.553;95% CI,1.266-24.361;P=0.023),and treatment-free survival(TFS)(?15 vs <15 months, HR,0.266; 95% CI,0.074-0.953 ; P=0.042) were indicated significant beneficial prognostic factors for overall survival(OS).Overall,pemetrexed-based rechallenge treatment was well tolerated.
Our results revealed that pemetrexed rechallenge strategy may be an option for advanced NSCLC patients who had shown beneficial response to previous pemetrexed-platinum chemotherapy.Therefore, patients with a PFS1 of ?10 months,TFS ?15 months,? 3rd line and rechallenge maintainance may be selected as benefit subgroups for pemetrexed rechallenge.