700P - A phase (Ph) I/II trial to evaluate the efficacy (E) and safety (S) of nab-paclitaxel (nab-P) in combination (Co) with gemcitabine (G) for the trea...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Cancer in Special Situations
Pancreatic Cancer
Presenter CARMEN Guillen-Ponce
Citation Annals of Oncology (2014) 25 (suppl_4): iv210-iv253. 10.1093/annonc/mdu334
Authors C. Guillen-Ponce1, R. Lopez2, T. Macarulla3, F. Rivera4, A. Cubillo5, A. Carrato1, E. Brozos2, T. Sauri Nadal3, C. López4, M. Hidalgo5
  • 1Medical Oncology Department, RAMON Y CAJAL UNIVERSITY HOSPITAL, 28034 - MADRID/ES
  • 2Medical Oncology, Complejo Hospitalario Universitario de Santiago de Compostela SERGAS, 15706 - Santiago de Compostela/ES
  • 3Oncology Service, Vall d`Hebron University Hospital Institut d'Oncologia, 08035 - Barcelona/ES
  • 4Medical Oncology, Hospital Universitario Marques de Valdecilla, Santander/ES
  • 5Ciocc, Hospital Madrid Norte Sanchinarro Centro Integral Oncologico Clara Campal, 28029 - Madrid/ES

Abstract

Aim

Nab-P + G significantly improved overall survival (OS) versus (vs) G in P with Karnofski index ≥70% metastatic PC (Von Hoff et al, 2013). In previously untreated (UT) Fr P with aPC, the aim of this Ph I/II trial is to select the dose (D)-schemes (Sc) of nab-P + G (Ph I), and to evaluate the E of nab-P + G in 2 D-Sc selected from the Ph I trial vs G alone (Ph II).

Methods

In Fr patients, performance status ECOG (Eastern Cooperative Oncology Group) = 2, with previously UT aPC, this trial is performed in 2 stages: Ph I: An open and randomized (R) (1:1:1:1) trial with 4 parallel arms (6 P/arm ): Arm B: nab-P 150 mg/m2 intravenous (IV) + G 1000 mg/m2 IV on days (d) 1 and 15/28 d. Arm C: nab-P 100 mg/m2 IV + G 1000 mg/m2 IV, d 1, 8 and 15/28 d. Arm D: nab-P 125 mg/m2 IV + G 1000 mg/m2 IV on d 1 and 15/28 d. Arm E: nab-P 125 mg/m2 IV + G 1000 mg/m2 IV, d 1, 8 and 15/28 d. Primary endpoint (PE): tolerability; analyzing grade (G) 4 hematological toxicity (HT), G3 and 4 non-HT and also early (Ea) mortality at 30 and 60 d, Ea discontinuation (Dis) for T and D intensity (In). Ph II: The 2 Sc chosen from Ph I will be evaluated in an open trial with the 2 selected arms of experimental Sc of nab-P + G.

Results

Between April 2013 and November 2013 Ph I trial recruitment was completed. The safety analysis was performed after 2 cycles of Tr. Five P had G3 Non-HT; they were fatigue (2), liver failure (1), constipation (1) and enteritis (1). Two P had G3 neutropenia (1) or G4 leucopenia (1) for <7 d. In arms B and E, 2 P had G3-4 AEs; while in arm D there was 0. In arm D there was 1 Ea Tr Dis for G2 anemia with impaired. There were 5 (20.8%) Ea deaths in <60 d, 2 of them in <30 d (arms B and D). In arms C and E, D-In of nab-P and G was higher (B, C, D, E: 63.7, 74.8, 62.5 and 90.3 mg/m2/week and 424.6, 748.3, 500.0 and 721.2 mg/m2/week respectively). Median number of administered cycles was 1.5, 2.5, 1.5 and 3.5 respectively. Three patients achieved clinical benefit (complete or partial response or stable disease) in arms C and E and 1 in arm D.

Conclusions

Nab-P + G is well tolerated in Fr P with aPC. Weekly administration of nab-P + G are better tolerated than biweekly ones. The D-Sc chosen for Ph II trial are the arms C and E.

Disclosure

All authors have declared no conflicts of interest.