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Showing content from https://pubmed.ncbi.nlm.nih.gov/30523758/ below:

Phase I/II Trial to Evaluate the Efficacy and Safety of Nanoparticle Albumin-Bound Paclitaxel in Combination With Gemcitabine in Patients With Pancreatic Cancer and an ECOG Performance Status of 2

Clinical Trial

. 2019 Jan 20;37(3):230-238. doi: 10.1200/JCO.18.00089. Epub 2018 Dec 4. Phase I/II Trial to Evaluate the Efficacy and Safety of Nanoparticle Albumin-Bound Paclitaxel in Combination With Gemcitabine in Patients With Pancreatic Cancer and an ECOG Performance Status of 2 Roberto Pazo-Cid², Carmen Guillén-Ponce³, Rafael López⁴, Ruth Vera⁵, Margarita Reboredo⁶, Andrés Muñoz Martin⁷, Fernando Rivera⁸, Roberto Díaz Beveridge⁹, Adelaida La Casta¹⁰, José Martín Valadés¹¹, Joaquina Martínez-Galán¹², Immaculada Ales¹³, Javier Sastre¹⁴, Sofia Perea¹⁵, Manuel Hidalgo¹⁵

Affiliations

¹ 1 Vall d'Hebrón University Hospital and Vall d'Hebrón Institute of Oncology, Barcelona, Spain.
² 2 Hospital Universitario Miguel Servet, Zaragoza, Spain.
³ 3 Hospital Universitario Ramón y Cajal, Madrid, Spain.
⁴ 4 Hospital Clínico de Santiago, Santiago de Compostela, Spain.
⁵ 5 Hospital de Navarra, Pamplona, Spain.
⁶ 6 Hospital Universitario A Coruña, A Coruña, Spain.
⁷ 7 Hospital General Universitario Gregorio Marañón, Madrid, Spain.
⁸ 8 Hospital Universitario Marqués de Valdecilla, Santander, Spain.
⁹ 9 Hospital Universitari i Politècnic La Fe, Valencia, Spain.
¹⁰ 10 Hospital Universitario Donostia, Donostia, Spain.
¹¹ 11 Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.
¹² 12 Hospital Universitario Virgen de las Nieves, Granada, Spain.
¹³ 13 Hospital Universitario Carlos Haya, Málaga, Spain.
¹⁴ 14 Hospital Clínico Universitario San Carlos, Madrid, Spain.
¹⁵ 15 Centro Nacional de Investigaciones Oncológicas and Centro Integral Oncológico Clara Campal, Madrid, Spain.

PMID: 30523758
DOI: 10.1200/JCO.18.00089

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Clinical Trial

Phase I/II Trial to Evaluate the Efficacy and Safety of Nanoparticle Albumin-Bound Paclitaxel in Combination With Gemcitabine in Patients With Pancreatic Cancer and an ECOG Performance Status of 2

Teresa Macarulla et al. J Clin Oncol. 2019.

. 2019 Jan 20;37(3):230-238. doi: 10.1200/JCO.18.00089. Epub 2018 Dec 4. Authors Teresa Macarulla¹, Roberto Pazo-Cid², Carmen Guillén-Ponce³, Rafael López⁴, Ruth Vera⁵, Margarita Reboredo⁶, Andrés Muñoz Martin⁷, Fernando Rivera⁸, Roberto Díaz Beveridge⁹, Adelaida La Casta¹⁰, José Martín Valadés¹¹, Joaquina Martínez-Galán¹², Immaculada Ales¹³, Javier Sastre¹⁴, Sofia Perea¹⁵, Manuel Hidalgo¹⁵ Affiliations

¹ 1 Vall d'Hebrón University Hospital and Vall d'Hebrón Institute of Oncology, Barcelona, Spain.
² 2 Hospital Universitario Miguel Servet, Zaragoza, Spain.
³ 3 Hospital Universitario Ramón y Cajal, Madrid, Spain.
⁴ 4 Hospital Clínico de Santiago, Santiago de Compostela, Spain.
⁵ 5 Hospital de Navarra, Pamplona, Spain.
⁶ 6 Hospital Universitario A Coruña, A Coruña, Spain.
⁷ 7 Hospital General Universitario Gregorio Marañón, Madrid, Spain.
⁸ 8 Hospital Universitario Marqués de Valdecilla, Santander, Spain.
⁹ 9 Hospital Universitari i Politècnic La Fe, Valencia, Spain.
¹⁰ 10 Hospital Universitario Donostia, Donostia, Spain.
¹¹ 11 Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.
¹² 12 Hospital Universitario Virgen de las Nieves, Granada, Spain.
¹³ 13 Hospital Universitario Carlos Haya, Málaga, Spain.
¹⁴ 14 Hospital Clínico Universitario San Carlos, Madrid, Spain.
¹⁵ 15 Centro Nacional de Investigaciones Oncológicas and Centro Integral Oncológico Clara Campal, Madrid, Spain.

PMID: 30523758
DOI: 10.1200/JCO.18.00089

Item in Clipboard

Abstract

Purpose: Gemcitabine plus nanoparticle albumin-bound (NAB) paclitaxel (GA) significantly improved survival compared with gemcitabine alone in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) and a Karnofsky performance status (PS) of 70% or greater. Because of the low number of patients with reduced PS, the efficacy of this regimen in fragile patients remains unclear. This study aimed to evaluate the efficacy and tolerability of different GA dosing regimens in patients with a poor PS.

Patients and methods: In the phase I part of this study, patients were randomly assigned to one of the following four parallel GA treatment arms (six patients per arm): a biweekly schedule of NAB-paclitaxel (150 mg/m² [arm A] or 125 mg/m² [arm C]) plus gemcitabine 1,000 mg/m² or a standard schedule of 3 weeks on and 1 week off of NAB-paclitaxel (100 mg/m² [arm B] or 125 mg/m² [arm D]) plus gemcitabine 1,000 mg/m². The two regimens with the better tolerability profile on the basis of predefined criteria were evaluated in the phase II part of the study, the primary end point of which was 6-month actuarial survival.

Results: Arms B and D were selected for the phase II part of the study. A total of 221 patients (111 patients in arm B and 110 patients in arm D) were enrolled. Baseline characteristics including median age (71 and 68 years in arms B and D, respectively), sex (51% and 55% men in arms B and D, respectively), and metastatic disease (88% and 84% in arms B and D, respectively) were comparable between arms. The most frequent grade 3 or 4 toxicities in arms B and D were anemia (12% and 7%, respectively), neutropenia (32% and 30%, respectively), thrombocytopenia (7% and 11%, respectively), asthenia (14% and 16%, respectively), and neurotoxicity (11% and 16%, respectively). In arms B and D, there were no significant differences in response rate (24% and 28%, respectively), median progression-free survival (5.7 and 6.7 months, respectively), and 6-month overall survival (63% and 69%, respectively).

Conclusion: NAB-paclitaxel administered at either 100 and 125 mg/m² in combination with gemcitabine on days 1, 8, and 15 every 28 days is well tolerated and results in acceptable safety and efficacy in patients with metastatic pancreatic ductal adenocarcinoma and a poor PS.

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