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Phase II clinical trial of nab-paclitaxel plus gemcitabine in elderly patients with previously untreated locally advanced or metastatic pancreatic adenocarcinoma: the BIBABRAX study

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Abstract

Purpose

To evaluate the health-related quality of life (HRQoL), global health status (GHS), and deterioration-free survival of an elderly population (> 70 years) with unresectable locally advanced (LAPC) or metastatic pancreatic cancer (mPC) treated with nab-paclitaxel in combination with gemcitabine.

Methods

In this open-label, single-arm, multicenter, phase II trial, patients received 4-week cycles of intravenous (i.v.) nab-paclitaxel at a dose of 125 mg/m2, followed by i.v. injections of gemcitabine at a dose of 1000 mg/m2 on days 1, 8 and 15 until disease progression or unacceptable toxicity was observed. The primary outcome was the HRQoL (deterioration-free rate at 3 months as evaluated with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30.

Results

Eighty patients (median age: 74.6 years) were enrolled (56 with mPC, 24 with LAPC). The percentage of patients who had not experienced deterioration at 3 months was 54.3% (95% CI 41.6–67.0%). The median (interquartile range) time until definite deterioration was 1.6 (1.1–3.7) months. The objective response rate and clinical benefit rate were achieved by 11 (13.8%, 95% CI 6.2–21.3%) and 54 patients (67.5%, 95% CI 57.2–77.8%), respectively. The median overall survival was 9.2 months (95% CI 6.9–11.5), and the median progression-free survival was 7.2 months (95% CI 5.8–8.5). Only fatigue and neutropenia demonstrated a grade 3–4 toxicity incidence > 20%.

Conclusions

Our study confirms the clinical benefit of the combination of nab-paclitaxel and gemcitabine in an elderly population with pancreatic cancer in terms of improved survival and clinical response. However, we were unable to confirm a benefit in terms of quality-of-life.

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Acknowledgements

The authors thank Juan Luis Sanz and Susana Vara (Apices, Madrid; Spain) for their support with study design, setup, coordination and project management, monitoring, statistical analysis and medical writing.

Funding

The BIBABRAX study was funded by Celgene. Medical writing assistance in the preparation of this paper was provided by Apices with financial support from Celgene.

Author information

Authors and Affiliations

  1. Medical Oncology Department, IdiPAZ, CIBERONC, Cátedra UAM-AMGEN, Hospital Universitario La Paz, Paseo de la Castellana 261., 28046, Madrid, Spain

    Jaime Feliu

  2. Medical Oncology Department, Hospital Álvaro Cunqueiro, Vigo, Spain

    Mónica Jorge Fernández

  3. Medical Oncology Department, Vall d’Hebrón University Hospital and Vall d’Hebrón Institute of Oncology, IOB Quirón, Barcelona, Spain

    Teresa Macarulla

  4. Medical Oncology Department, Alicante University Hospital ISABIAL, Alicante, Spain

    Bartomeu Massuti

  5. Medical Oncology Department, Hospital Virgen Macarena, Sevilla, Spain

    Ana Albero

  6. Medical Oncology Department, Hospital Universitario Quirónsalud Madrid, Madrid, Spain

    José Federico González González

  7. Medical Oncology Department, Hospital Universitario Lucus Augusti (HULA), Lugo, Spain

    Guillermo Quintero-Aldana

  8. Medical Oncology Department, Hospital Universitario Badajoz, Badajoz, Spain

    Juan Ignacio Delgado-Mingorance

  9. Medical Oncology Department, Complexo Hospitalario Universitario de Ourense, Ourense, Spain

    Ana Fernández Montes

  10. Medical Oncology Department, Hospital Insular de Gran Canaria, Las Palmas de Gran Canaria, Spain

    Carmen García Piernavieja

  11. Medical Oncology Department, Instituto de Biomedicina de Sevilla, Hospital Universitario Virgen del Rocio, Sevilla, Spain

    Manuel Valladares-Ayerbes

  12. Medical Oncology Department, Hospital Universitario de Burgos, Burgos, Spain

    Ana María López Muñoz

  13. Medical Oncology Department, Hospital Universitario La Princesa, Madrid, Spain

    Rebeca Mondéjar Solís

  14. Medical Oncology Department, Hospital Granollers, Granollers, Spain

    Pilar Vicente

  15. Medical Oncology Department, Hospital Althaia, Manresa, Spain

    Esther Casado Gonzalez

  16. Digestive Cancer Department, San Cecilio Hospital, Granada, Spain

    Irene González Cebrián

  17. Medical Oncology Department, Hospital Universitario Cruces, Barakaldo, Spain

    Guillermo López-Vivanco

Authors
  1. Jaime Feliu
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  2. Mónica Jorge Fernández
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  3. Teresa Macarulla
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  4. Bartomeu Massuti
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  5. Ana Albero
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  6. José Federico González González
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  7. Guillermo Quintero-Aldana
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  8. Juan Ignacio Delgado-Mingorance
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  11. Manuel Valladares-Ayerbes
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  12. Ana María López Muñoz
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  14. Pilar Vicente
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  15. Esther Casado Gonzalez
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  16. Irene González Cebrián
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  17. Guillermo López-Vivanco
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Corresponding author

Correspondence to Jaime Feliu.

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Conflicts of interest

J. Feliu has received consulting and has had an advisory role in Amgen, Ipsen, Eisai, Merck, Roche and Novartis, has received research funding from Merck and Amgen; he has received travel and accommodation expenses from Amgen and Servier. M. Jorge Fernández has been member of the advisory boards from Amgen and Celgene; she has received speaker honorarium from Merck, Roche and Servier; she has received consulting honorarium from Lilly, she has received travel grants from Merck. T. Macarulla has played a consultant or advisory role with Amgen, Baxter, Celgene, Incyte, Q&D Therapeutics, Servier and Shire; she has received research funding from AstraZeneca, BeiGEne and Celgene. B. Massuti has been member of the advisory boards for Roche, MSD and BMS; he has received speaker honorarium from AstraZeneca, Servier, BMS and Roche; he has received research grants to institution from ISCIII; he has received travel grants from AstraZeneca and MSD. A. Albero reports no conflict of interest. J. F. González González reports no conflict of interest. G. Quintero-Aldana reports no conflict of interest. J.I. Delgado-Mingorance reports no conflict of interest. A. Fernández Montes reports no conflict of interest. C. García Piernavieja reports no conflict of interest. M. Valladares-Ayerbes has been member of the advisory boards for Merck, Amgen and Sanofi; he has received research grants to institution from Roche; he has received personal fees from Merck, Amgen and personal fees from Sanofi during the conduct of the study; he has received personal fees from Servier, personal fees from Bayer, personal fees from Celgene, outside the submitted work. A.M. López Muñoz reports no conflict of interest. R. Móndejar Solís has been member of the advisory boards for Amgen, Merck, Roche, Pfizer, Servier and Celgene; she has received speaker honorarium from Amgen, Merck, Roche, Pfizer, Servier and Celgene. P. Vicente reports no conflict of interest. E. Casado González reports no conflict of interest. I. González Cebrián has been member of the advisory board for Celgene. G. López-Vivanco reports no conflict of interest.

Ethical approval

The study protocol was approved by the independent ethics committee of the Ethical Research Committee of the Puerta de Hierro-Majadahonda University Hospital, and the study was conducted in compliance with the Good Clinical Practice Guidelines and in accordance with the ethical principles of the Declaration of Helsinki. Written informed consent was obtained from all patients before they entered the study. The trial was registered at ClinicalTrials.gov under number NCT02391662.

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Supplementary file1 (DOCX 114 KB) Fig. S1 Kaplan-Meier curve of overall survival. Fig. S2 Kaplan-Meier curve of progression-free survival.

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Feliu, J., Jorge Fernández, M., Macarulla, T. et al. Phase II clinical trial of nab-paclitaxel plus gemcitabine in elderly patients with previously untreated locally advanced or metastatic pancreatic adenocarcinoma: the BIBABRAX study. Cancer Chemother Pharmacol 87, 543–553 (2021). https://doi.org/10.1007/s00280-020-04214-w

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