Memorial Sloan Kettering Cancer Center, New York, NY
Robert J. Motzer , Camillo Porta , Boris Alekseev , Sun Young Rha , Toni K. Choueiri , Maria Jose Mendez-Vidal , Sung-Hoo Hong , Anil Kapoor , Jeffrey C. Goh , Masatoshi Eto , Jinyi Wang , Janice Pan , Alemseged Ayele Asfaw , Cixin Steven He , Kalgi Mody , David Cella
Background: LEN + PEMBRO improved PFS, OS and ORR vs SUN in the first-line treatment of pts with aRCC; LEN + EVE improved PFS and ORR vs SUN (Motzer R et al. NEJM. 2021). We report results of a secondary objective of the CLEAR trial comparing the impact of LEN + PEMBRO or EVE vs SUN, on HRQoL. Methods: Pts (N=1069) were randomized (1:1:1) to receive LEN 20 mg PO QD + PEMBRO 200 mg IV Q3W; LEN 18 mg + EVE 5 mg PO QD; or SUN 50 mg PO QD (4 wks on/2 wks off). HRQoL was assessed per FKSI-DRS, EORTC QLQ-C30, and EuroQoL EQ-5D-3L, at baseline, on day 1 of subsequent 3 wk cycles starting with cycle 2, and at the off-treatment visit. HRQoL analyses (unless otherwise noted) were based on data from randomized pts with any HRQoL data who received ≥1 dose of study treatment. No adjustments for multiple testing or estimation were used; P-values and CIs are nominal and descriptive. Results: For comparisons of LEN + PEMBRO vs SUN, overall changes from baseline at mean follow-up (wk 46) favored LEN + PEMBRO with significant differences between treatments for physical functioning (least squares mean difference [LS MD] [95% CI]: 3.0 [0.5, 5.5]) and fatigue (−2.8 [−5.5, −0.1]), dyspnea (−2.8 [−5.3, −0.3]), and constipation (−2.2 [−4.2, −0.2]). LS MD of the FKSI-DRS total score was 0.2 (−0.4, 0.7). For comparisons of LEN + EVE vs SUN, overall changes from baseline at wk 46 favored SUN with significant differences in overall HRQoL (−2.8 [−5.1, −0.5] assessed by the EORTC QLQ-C30 GHS/QoL scale) and pain (2.8 [0.1, 5.5]), appetite loss (4.2 [1.3, 7.1]), and diarrhea (5.3 [2.6, 7.9]). LS MD of the FKSI-DRS total score was −0.4 (−1.0, 0.2). 14 of 18 scales for both LEN + PEMBRO and LEN + EVE vs SUN had no significant differences in LS MD comparisons. The LEN + PEMBRO arm is favored over SUN for the median time to first deterioration (TTD) for physical functioning, dyspnea, appetite loss and EQ-5D VAS (Table). 15 of 19 scales for both LEN + PEMBRO and LEN + EVE vs SUN had no significant differences in TTD comparisons. Conclusions: Compared with SUN, pts in LEN + PEMBRO group had similar or better symptoms and HRQoL. Clinical trial information: NCT02811861
Scale | Median TTD, wks | HR (95% CI) | |||
---|---|---|---|---|---|
LEN + PEMBRO | LEN + EVE | SUN | LEN + PEMBRO vs SUN | LEN + EVE vs SUN | |
FKSI-DRS total score (3-point MID) | 9.1 | 7.9* | 12.1 | 1.1 (0.9, 1.4) | 1.2 (1.0, 1.5) |
EORTC QLQ-C30: Physical functioning | 15.3* | 9.4 | 12.7 | 0.8 (0.7, 1.0) | 1.1 (0.9, 1.3) |
Pain | 7.1 | 6.1* | 9.9 | 1.1 (0.9, 1.3) | 1.3 (1.1, 1.5) |
Dyspnea | 39.3* | 18.4 | 21.1 | 0.8 (0.6, 1.0) | 1.1 (0.9, 1.3) |
Appetite Loss | 18.3* | 8.9 | 9.1 | 0.8 (0.7, 1.0) | 1.2 (1.0, 1.4) |
Diarrhea | 15.4 | 9.6* | 15.1 | 0.9 (0.7, 1.1) | 1.3 (1.1, 1.6) |
EQ-5D Index | 9.1 | 6.3* | 15.0 | 1.1 (0.9, 1.3) | 1.3 (1.1,1.5) |
EQ-5D VAS (7-point MID) | 9.4* | 6.4 | 9.1 | 0.8 (0.7, 1.0) | 1.1 (0.9, 1.3) |
*Statistically significant log-rank difference of distribution of TTD (P<0.05) vs SUN.
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Abstract Disclosures
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