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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)

Date

09 Sep 2017

Session

Poster display session

Topics

Cytotoxic Therapy;  Pancreatic Cancer

Presenters

Fabienne Portales

Citation

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

Authors

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
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Resources

Abstract 3211

Background

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.

Methods

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.

Results

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 (%)
Anxiety
 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
a

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

b

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

Conclusions

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

NCT02301143

Legal entity responsible for the study

Celgene Corporation

Funding

Celgene Corporation

Disclosure

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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