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Poster display session

3211 - Interim Health Related Quality of Life (QoL) from LAPACT, a Phase 2 Trial of nab-Paclitaxel (nab-P) Plus Gemcitabine (G) for Patients (Pts) With Locally Advanced Pancreatic Cancer (LAPC)


09 Sep 2017


Poster display session


Cytotoxic Therapy;  Pancreatic Cancer


Fabienne Portales


Annals of Oncology (2017) 28 (suppl_5): v209-v268. 10.1093/annonc/mdx369


F. Portales1, P.A. Philip2, P. Hammel3, M. Buscaglia4, R. Pazo-Cid5, J.L. Manzano-Mozo6, E.S. Kim7, S. Dowden8, A. Zakari9, C. Borg10, E. Terrebonne11, F. Rivera Herrero12, J. Shiansong Li13, T.J. Ong14, T. Nydam14, J. Lacy15

Author affiliations

  • 1 Oncologue Digestif, Institut régional du Cancer de Montpellier (ICM), 34298 - Montpellier/FR
  • 2 Department Of Oncology, Karmanos Cancer Institute, 48201 - Detroit/US
  • 3 Gastroenterology, Hôpital Beaujon, 92110 - Clichy/FR
  • 4 Medical Oncology, Azienda Ospedaliera Universitaria San Martino, 16132 - Genova/IT
  • 5 Medical Oncology, Hospital Miguel Servet, 50009 - Zaragoza/ES
  • 6 Medical Oncology, Hospital Universitari Germans Trias i Pujol, Barcelona/ES
  • 7 Medical Oncology, Levine Cancer Institute, Charlotte/US
  • 8 Medical Oncology, Tom Baker Cancer Center, T2N 4N2 - Calgary/CA
  • 9 Gastro Intestinal Cancer Program, Florida Hospital Cancer Institute, 32804 - Orlando/US
  • 10 Medical Oncology, Centre Hospitalier Belfort Montbeliard, Montbeliard/FR
  • 11 Medical Oncology, Hospital Haut Leveque, Giround/FR
  • 12 Medical Oncology, Hospital Universitario Marques de Valdecilla, 39008 - Santander/ES
  • 13 Biostatistics, Celgene Corporation, 07901 - Summit/US
  • 14 Medical Affairs, Celgene Corporation - USA, 07901 - Summit/US
  • 15 Medical Oncology, Yale Cancer Center, 06510 - New Haven/US


Abstract 3211


Disease burden and cumulative toxicity due to chemotherapy may negatively impact QoL of pts with cancer. Early results from the LAPACT trial suggest promising efficacy of nab-P + G in LAPC. An evaluation of the potential impact of nab-P + G on health-related QoL is warranted.


During induction, treatment-naive pts with unresectable LAPC and ECOG PS ≤ 1 received 6 cycles (C) of nab-P 125 mg/m2 + G 1000 mg/m2 D 1, 8, and 15 of each 28-day C. After induction, pts without PD or unacceptable AEs were eligible for the investigator’s choice (IC) of continued treatment (Tx) with nab-P + G, chemoradiation, or surgery. Surgery could occur prior to completing 6 C if the investigator deemed a sufficient tumor response. Pt-reported QoL, a secondary endpoint, was assessed via EORTC QLQ-C30 and QLQ-PAN26 at initial screening, during the induction and IC phases on D 1 of each C, and at follow-up after the last dose. Results presented here are from the induction phase. Data for pts receiving their first Tx dose by Oct 1, 2016 are reported.


A total of 101 pts received Tx, and 75% (76/101) pts had a baseline and ≥ 1 postbaseline QoL assessment. The median age was 65 years (range, 42-85); 53% had an ECOG PS 1. All QoL dimensions were improved/stable in ≥ 67% of pts (Table). In general, median time to improvement was ≤ 1 week of completing the first Tx C (28 days/C). A majority (> 60%) of pts had ≥ 1 complete resolution of anxiety (tense), constipation, depression, nausea, or pain during induction. Forty-two percent of pts received additional Tx during the IC phase.Table:

730P Stability, Improvement, and Resolution in the EORTC-QLQ C30

DimensionaStable or Improved, %b (n = 76 evaluable)Median Time to Improvement, daysComplete Resolution at Least Once, n/nb (%)
 Tense90.832.034/54 (63.0)
 Worry86.831.529/63 (46.0)
Constipation88.229.028/39 (71.8)
Depression85.529.021/32 (65.6)
Difficulty remembering things86.832.014/25 (56.0)
Fatigue76.330.010/63 (15.9)
Insomnia85.534.028/55 (50.9)
Irritability86.831.520/40 (50.0)
Lacked appetite85.533.030/52 (57.7)
Limited in pursuing hobbies or leisure77.634.513/37 (35.1)
Limited in work or other daily activity82.930.013/38 (34.2)
Nausea88.250.022/28 (78.6)
Need to rest81.633.07/58 (12.1)
Need to stay in bed or chair during day85.551.015/33 (45.5)
Pain90.829.036/59 (61.0)
Pain interfering with daily activity90.830.026/39 (66.7)
Physical condition or medical treatment
 Caused financial difficulties90.835.012/25 (48.0)
 Interfered with family life76.337.017/31 (54.8)
 Interfered with social activities81.652.016/42 (38.1)
Trouble doing strenuous activity81.629.54/40 (10.0)
Trouble taking long walks77.630.07/45 (15.6)
Weakness67.130.014/53 (26.4)
Overall health75.033.0not applicable

Dimensions included were those experienced by ≥ 25 pts at baseline and evaluable at ≥ 1 postbaseline assessment. All were measured during induction phase.


Pts who had ≥ 1 complete resolution of the limitation/pts who experienced the limitation.


QoL was generally improved/stable during induction, with some dimensions improving within 1 week of completing the first C. This suggests that QoL is preserved or improved with nab-P + G and indicates that the regimen was active and tolerable, with a majority of pts completing induction without PD. NCT02301143.

Clinical trial identification


Legal entity responsible for the study

Celgene Corporation


Celgene Corporation


P.A. Philip: Research funding: Celgene, Bayer, Incyte; consultant or advisory role: Celgene; speaker’s bureau: Bayer, Roche, Sanofi, Amgen. P. Hammel: Consultant or advisory role, honoraria, and travel accommodations, expenses: Celgene. E.S. Kim Honoraria, speaker’s bureau, advisory board: GuardantHealth; consultant: Pharmacyclics; consultant: Medallion Healthcare; Advisory board: Bayer; Consultant: Momenta. S. Dowden: Honoraria, advisory role, speaker’s bureau: Amgen, Bayer, Celgene, Lilly, Roche. A. Zakari: Speaker\'s bureau: Amgen, Celgene. C. Borg, J. Lacy: Research funding: Celgene. F. Rivera Herrero: Research funding: Celgene, Bayer, Roche, Amgen, Merck-Serono, MSD, Sanofi, Lilly; consultant or advisory role: Celgene, Bayer, Roche, Amgen, Merck-Serono, MSD, Sanofi, Lilly; speaker’s bureau: Celgene, Bayer, Roche, Sanofi, Amgen, Lilly. J. Shiansong Li, T.J. Ong, T. Nydam: Employment, stock ownership, Celgene. All other authors have declared no conflicts of interest.

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