Nab-paclitaxel (Nab-P) and gemcitabine (G) as first-line chemotherapy (CT) in advanced pancreatic cancer (APDAC) elderly patients (pts): A “real-life” study.

Authors

null

Guido Giordano

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

Organizations

Medical Oncology Unit, Ospedale Sacro Cuore di Gesù, Fatebenefratelli,, Benevento, Italy, Regina Elena National Cancer Institute, Rome, Italy, Medical Oncology, University of Verona, Verona, Italy, U.O. Oncologia Medica II Universitaria Ospedale S. Chiara, Azienda Ospedaliero-Universitaria Pisana Istituto Toscano Tumori, Pisa, Italy, Department of Medical Oncology, Fondazione Poliambulanza, Brescia, Italy, Oncologia Medica I, Istituto Oncologico Veneto, IRCCS, Padova, Italy, Medical Oncology I, Azienda Ospedaliero Universitaria Careggi, Florence, Italy, Medical Oncology, Polytechnic University of the Marche Region, Azienda Ospedaliero-Universitaria, Ospedali Riuniti Umberto I-GM Lancisi and G Salesi, Ancona, Italy, Department of Medical Oncology Campus Bio-Medico University, Rome, Italy, Medical Oncology Unit, Ospedale Sacro Cuore di Gesù, Fatebenefratelli, Benevento, Italy, Department of Medical Oncology, Campus Bio-Medico University of Rome, Rome, Italy, Department of Medical Oncology, Casa di Cura Poliambulanza, Brescia, Italy, Clinica di Oncologia Medica, A.O. Ospedali Riuniti, Università Politecnica delle Marche, Ancona, Italy, U.O. Oncologia Medica II, Azienda Ospedaliero-Universitaria Pisana Istituto Toscano Tumori, Pisa, Italy

Research Funding

No funding sources reported

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.

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Abstract Details

Meeting

2015 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

General Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Track

Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Sub Track

Multidisciplinary Treatment

Citation

J Clin Oncol 33, 2015 (suppl 3; abstr 424)

DOI

10.1200/jco.2015.33.3_suppl.424

Abstract #

424

Poster Bd #

D43

Abstract Disclosures