Division of Gynecologic Oncology, Duke Cancer Institute, Duke University Medical Center, Durham, NC
Jonathan Foote , Laura Jean Havrilesky , Elizabeth Lin Jewell , Charlotte Gamble , Jessie Ehrisman , Gloria Broadwater , Robert L. Coleman , David E. Cohn , Angeles Alvarez Secord
Background: The ASCO value framework allows assessment of novel cancer therapies based on NHB. We assessed novel biologic therapies in the management of PSROC. Methods: ASCO’s revised value framework NHBs were constructed for key therapies based on randomized clinical trials for PSROC. BRCA-germline and HRD status were included. Additionally, patient-centered NHB calculations were weighted based on results from a prospective patient preferences study (n=54) and compared to ASCO-based NHB. Results: ASCO-centered NHB calculations were: platinum + taxane-based chemotherapy (ICON4) = 35; carboplatin + liposomal doxorubicin (CALYPSO) = 22; platinum-based chemotherapy + bevacizumab (OCEANS = 35; GOG 213 = 26). NHB scores based on germline-BRCA alterations were maintenance niraparib (NOVA) = 50 and maintenance olaparib (Study 19) = 62; wild-type BRCA, maintenance niraparib = 36 and maintenance olaparib = 33; and HRD-positive status, maintenance niraparib = 42. Patients valued clinical benefit as the most important component of NHB. Patients valued OS as the most important component of clinical benefit, followed by response rate (RR), then PFS. Patient-weighted NHB were significantly lower than ASCO-weighted scores (mean NHB 37.8 versus 23.5; p=0.009) due to decreased preference for PFS compared to other clinical benefit measures (Table). Conclusions: NHB scores for treatment of PSROC were highest in women with germline-BRCA and HRD tumor alterations who were treated with maintenance PARPi. Our data suggest that a patient-centered NHBs can be used to inform treatment decisions.
Regimens | ASCO NHB | Patient-weighted NHB | P value | |
---|---|---|---|---|
Platinum-based chemotherapy + taxane (ICON4) | 35 | 27 | 0.009 | |
Carbo + liposomal doxorubicin (CALYPSO) | 22 | 17 | ||
Platinum-based chemotherapy + bevacizumab | OCEANS | 35 | 20 | |
GOG 213 | 26 | 15 | ||
Maintenance olaparib (Study 19) | gBRCA | 62 | 38 | |
wBRCA | 33 | 20 | ||
Maintenance niraparib (NOVA) | gBRCA | 50 | 30 | |
wBRCA | 36 | 21 | ||
wBRCA HRD+ | 42 | 24 |
NHB = Net Health Benefit (based on PFS); gBRCA = germline BRCA alteration; wBRCA = wild-type germline BRCA; HRD = homologous recombination deficiency
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