Objectives: The aim of this study was to evaluate the efficacy and safety of the combination Gemcitabine (Gem) plus nab-Paclitaxel (NabP) (Gem/NabP), followed by maintenance Gem in older adults with locally advanced or metastatic pancreatic cancer (PC). Materials and methods: In this prospective observational study, the induction chemotherapy consisted of NabP 125 mg/m2 followed by Gem 1000 mg/m2 on days 1, 8, and 15 of a 4-week cycle. After a maximum of 3 cycles, patients without evidence of progressive disease (PD) were administered Gem 1000 mg/m2 weekly for 3 of 4 weeks as maintenance therapy until documentation of PD or unacceptable toxicity. The primary endpoint was six-month disease-control rate (DCR). Results: Overall, 36 patients >70 years with metastatic or locally advanced PC were enrolled at participating Institutions. After completion of Gem/NabP, 18 (50%) patients achieved partial response, 13 (36%) had stable disease, and 5 (14%) had PD. Thirty-one patients (86%) received Gem monotherapy as maintenance treatment for a median of 3 cycles (range, 2–9 cycles). Six-month DCR was 61% (95% CI, 45–77), median PFS was 6.4 months (95% CI, 5.4–8.3), and median OS was 13.4 months (95% CI, 11.1–16.7). During Gem/NabP regimen, the most common grade 3 toxicity included neutropenia (22%), anemia (19%) and thrombocytopenia (8%). Grade 3 neuropathy was not observed. During Gem maintenance therapy, grade 3 hematological toxicity was described in 6 patients (19%). Conclusion: Gem/NabP followed by maintenance Gem appears to be safe and effective for older patients with locally advanced or metastatic PC. © 2019 Published by Elsevier Ltd.

Petrioli, R., Torre, P., Pesola, G., Paganini, G., Paolelli, L., Miano, S.T., et al. (2020). Gemcitabine plus nab-paclitaxel followed by maintenance treatment with gemcitabine alone as first-line treatment for older adults with locally advanced or metastatic pancreatic cancer. JOURNAL OF GERIATRIC ONCOLOGY, 11(4), 647-651 [10.1016/j.jgo.2019.08.008].

Gemcitabine plus nab-paclitaxel followed by maintenance treatment with gemcitabine alone as first-line treatment for older adults with locally advanced or metastatic pancreatic cancer

Petrioli R.;Torre P.;Pesola G.;Miano S. T.;Martellucci I.;Francini G.;
2020-01-01

Abstract

Objectives: The aim of this study was to evaluate the efficacy and safety of the combination Gemcitabine (Gem) plus nab-Paclitaxel (NabP) (Gem/NabP), followed by maintenance Gem in older adults with locally advanced or metastatic pancreatic cancer (PC). Materials and methods: In this prospective observational study, the induction chemotherapy consisted of NabP 125 mg/m2 followed by Gem 1000 mg/m2 on days 1, 8, and 15 of a 4-week cycle. After a maximum of 3 cycles, patients without evidence of progressive disease (PD) were administered Gem 1000 mg/m2 weekly for 3 of 4 weeks as maintenance therapy until documentation of PD or unacceptable toxicity. The primary endpoint was six-month disease-control rate (DCR). Results: Overall, 36 patients >70 years with metastatic or locally advanced PC were enrolled at participating Institutions. After completion of Gem/NabP, 18 (50%) patients achieved partial response, 13 (36%) had stable disease, and 5 (14%) had PD. Thirty-one patients (86%) received Gem monotherapy as maintenance treatment for a median of 3 cycles (range, 2–9 cycles). Six-month DCR was 61% (95% CI, 45–77), median PFS was 6.4 months (95% CI, 5.4–8.3), and median OS was 13.4 months (95% CI, 11.1–16.7). During Gem/NabP regimen, the most common grade 3 toxicity included neutropenia (22%), anemia (19%) and thrombocytopenia (8%). Grade 3 neuropathy was not observed. During Gem maintenance therapy, grade 3 hematological toxicity was described in 6 patients (19%). Conclusion: Gem/NabP followed by maintenance Gem appears to be safe and effective for older patients with locally advanced or metastatic PC. © 2019 Published by Elsevier Ltd.
2020
Petrioli, R., Torre, P., Pesola, G., Paganini, G., Paolelli, L., Miano, S.T., et al. (2020). Gemcitabine plus nab-paclitaxel followed by maintenance treatment with gemcitabine alone as first-line treatment for older adults with locally advanced or metastatic pancreatic cancer. JOURNAL OF GERIATRIC ONCOLOGY, 11(4), 647-651 [10.1016/j.jgo.2019.08.008].
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11365/1092575