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 Anticancer Agents
Cancer in Special Situations
Pancreatic Cancer
Therapy
Biological Therapy
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.