Medical Oncology Unit, Ospedale Sacro Cuore di Gesù, Fatebenefratelli,, Benevento, Italy
Guido Giordano , Vanja Vaccaro , Eleonora Lucchini , Gianna Musettini , Paola Bertocchi , Francesca Bergamo , Elisa Giommoni , Matteo Santoni , Marco Russano , Serena Campidoglio , Daniele Santini , Alberto Zaniboni , Vittorina Zagonel , Stefano Cascinu , Enrico Vasile , Davide Melisi , Michele Milella , Antonio Febbraro
Background: Nab-P and G represents a standard of care in first line APDAC treatment. Neverthless, activity, efficacy and safety of Nab-P + G have not been established in elderly pts and clinical trials on APDAC treatment contain fewer elderly pts compared with everyday clinical practice. Aim of this analysis is to evaluate outcomes and toxicities of elderly pts treated with first line Nab-P + G in a “real world” population. Methods: Clinical records of APDAC pts receiving Nab-P 125 mg/m2 and G 1000 mg/m2on days 1,8 and 15 of a 28 day cycle as first line CT were retrospectively reviewed, investigating activity (Disease Control Rate, DCR: Stable Disease + Partial Response + Complete Response, SD+PR+CR), efficacy (Progression Free Survival, PFS and Overall Survival, OS) and safety. Analysis was then performed in ≥ 70 years group of pts. OS and PFS were estimated with Kaplan-Meyer method with 95% CI. Cox-regression model was applied to the data with univariate and multivariate approach. Results: 105 pts (M/F:58/47), median age 64 (range 37-77) ECOG Performance Status of 0/1/2: 46/41/17 respectively were included in our analysis. 37 pts (35%) were ≥ 70 years old. In overall population Nab-P+G was administered for a median number of 6 cycles (range 1-12). 4 CR, 24 PR and 28 SD were observed (DCR: 53%), median PFS was 7 months (95% C.I. 5.93 - 8.08) and median OS was 11 months (95% C.I. 9.58 – 12.41). Pts aged ≥ 70 received a median number of 5 cycles (range 1 - 10). DCR was 48% (9 PR + 9 SD) with no differences in PFS (6.5 months, 95%C.I. 5.36 – 7.64, p=0.49) and OS (10 months, 95% C.I. 8.53 – 11.47 p=0.67) with < 70 years old pts. Treatment was mildly tolerated and toxicity profile appeared to be different in elderly pts than younger ones with more G3-4 non-haematological (27% vs 15% p=0.03) and fewer haematological (12% vs 29% p=0.004) events respectively. Conclusions: These data, evaluated under daily practice conditions, in absence of clinical trials on APDAC elderly pts, show that pts aged ≥ 70 may benefit of first-line Nab-P and G combination, as well as younger ones, both in terms of response and survival experiencing a tolerable, but significantly different toxicity profile.
Disclaimer
This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org
Abstract Disclosures
2024 ASCO Gastrointestinal Cancers Symposium
First Author: Kenji Ikezawa
2024 ASCO Gastrointestinal Cancers Symposium
First Author: Kohei Shitara
2021 ASCO Annual Meeting
First Author: Marta Chiaravalli
2023 ASCO Annual Meeting
First Author: Yelena Y. Janjigian