Additional therapy nab-Paclitaxel following pancreatic cancer surgery

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Open-label, Randomized Study of nab®-Paclitaxel plus Gemcitabine versus Gemcitabine alone as Adjuvant therapy in subjects with Surgically Resected Pancreatic Adenocarcinoma

• IRAS ID

  143422

• Contact name

  Jeff Evans

• Contact email

  j.evans@beatson.gla.ac.uk

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2013-003398-91

• Clinicaltrials.gov Identifier

  NCT01964430

• Research summary

  Summary of Results

  Overall Survival: The final OS data presented in this closeout CSR were 92% mature (582/630 events). Similar to what was reported previously in the ABI-007-PANC-003 CSR, OS was longer in the nab-paclitaxel plus gemcitabine arm compared with the gemcitabine arm (median OS: 41.8 vs 37.7 months; hazard ratio [HR] (95% confidence interval [CI]) = 0.81 (0.691, 0.957). In the nab-paclitaxel plus gemcitabine arm 66% of subjects had died compared with 68% of subjects in the gemcitabine arm.
  The OS rate (Kaplan-Meier [KM] estimate) was consistently higher in the nab-paclitaxel plus gemcitabine arm than in the gemcitabine arm throughout the study from randomization of the first subject, with 72-month OS rates of 33% in the nab-paclitaxel + gemcitabine arm and 27% in the gemcitabine arm.
  Censoring rates were similar for both treatment arms (34% and 32% in the nab-paclitaxel plus gemcitabine arm and the gemcitabine arm, respectively) and the median survival follow-up time for censored subjects was similar for both treatment arms (77.8 months and 77.8 months in the nab-paclitaxel plus gemcitabine arm and the gemcitabine arm, respectively).
  Subgroup Analysis: Subgroup analyses were pre-specified and only included subjects with corresponding baseline data (clinical data). The OS HRs for all subgroups except the subgroup with a tumor grade of poorly differentiated or undifferentiated favored (HR < 1) the nab-paclitaxel plus gemcitabine arm over the gemcitabine arm. These results are consistent with those in the ABI-007-PANC-003 Final CSR.
  Multivariate Analysis: A multivariate analysis of OS was conducted using a Cox proportional hazard model to evaluate the treatment effect adjusted for the randomization stratification factors of resection status, nodal status, and geographical region. Consistent with the results in the ABI-007-PANC-003 Final CSR, the model indicated that resection status and nodal status had a significant impact on OS, whereas geographical region did not. Treatment effect was also significant (HR 0.82, p = 0.0154) .
  A similar proportion of subjects in each arm received a subsequent anti-cancer therapy.
  Although this study did not meet its primary endpoint of independently assessed disease free survival
  (DFS) in the primary analysis, study close-out final OS data continue to suggest improved survival with nab-paclitaxel plus gemcitabine when compared with gemcitabine alone for the adjuvant treatment of resected pancreatic adenocarcinoma

• REC name

  West of Scotland REC 1

• REC reference

  14/WS/0068

• Date of REC Opinion

  12 May 2014

• REC opinion

  Further Information Favourable Opinion