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Poster display session

4675 - First-line panitumumab (P) plus capecitabine (C) for the treatment of elderly patients (pts) with wild-type KRAS metastatic colorectal cancer (mCRC). Preliminary results of the phase II, PANEL GITuD-2011-01 study

Date

09 Sep 2017

Session

Poster display session

Topics

Cytotoxic Therapy;  Geriatric Oncology;  Colon and Rectal Cancer

Presenters

José Carlos Méndez Méndez

Citation

Annals of Oncology (2017) 28 (suppl_5): v158-v208. 10.1093/annonc/mdx393

Authors

J.C. Méndez Méndez1, M. Ramos2, J.C. De la Cámara Gómez3, M.L. Pellón3, M. Covela4, G.A. Quintero Aldana5, M. Salgado Fernandez6, A. Fernández-Montes7, M. Reboredo8, M. Valladares-Ayerbes9, M. Jorge Fernandez10, P. González Villarroel10, C. Romero Reinoso11

Author affiliations

  • 1 Medical Oncology, Centro Oncológico de Galicia, 15009 - A Coruña/ES
  • 2 Medical Oncology, Centro Oncologico de Galicia, A Coruña/ES
  • 3 Medical Oncology, Complejo Hospitalario Universitario Ferrol, Ferrol/ES
  • 4 Medical Oncology, Hospital Universitario Lucus Augusti, Lugo/ES
  • 5 Medical Oncology, HOSPITAL UNIVERSITARIO LUCUS AUGUSTI, Lugo/ES
  • 6 Medical Oncology, Complejo Hospitalario De Ourense, 32005 - Ourense/ES
  • 7 Medical Oncology, Complejo Hospitalario Universitario de Ourense, Orense/ES
  • 8 Medical Oncology Department, Hospital Universitario a Coruna - a Coruna, 15006 - A Coruna/ES
  • 9 Medical Oncology, Hospital Virgen del Rocío, Sevilla/ES
  • 10 Medical Oncology, Complejo Universitario Hospitalario Álvaro Cunqueiro, 36204 - Vigo/ES
  • 11 Medical Oncology, Hospital Povisa, Vigo/ES
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Resources

Abstract 4675

Background

Despite the high prevalence of CRC in elderly pts (Siegel R et al. 2014), they have been underrepresented in clinical trials (Hutchins LF et al. 1999) and their optimal treatment is yet to be determined. Here, we present the preliminary results of PANEL, a multicenter, single arm, phase II study in elderly pts with WT KRAS mCRC treated with P+C as first-line regimen.

Methods

Pts (≥70 years; ECOG-PS ≤ 2) received P (9 mg/kg, day 1 and q3w) plus C (850 mg/m2 BID, days 1-14 of a 3 wks cycle) until disease progression or unacceptable toxicity. Response was evaluated every 9 wks according to RECIST 1.1. The outcome measures were: objective response rate (ORR), duration of response (DoR), time to response (TTR), to progression (TTP) and to treatment failure (TTF), progression-free survival (PFS), overall survival (OS), and safety.

Results

26 pts (11 women; median age: 78 years; ECOG PS: 0 [27%]/1 [65%]/2 [8%]; median serum carcinoembryonic antigen: 25.2 ng/ml [IQR: 93.5]; median lactate dehydrogenase: 340 U/L [IQR: 195]) received a mean (SD) of 8.3 (5.5) P cycles and 7.7 (4.8) C cycles. 81% and 62% of pts received ≥80% of relative dose intensity of P and C, respectively. Confirmed ORR was 38%, with 69% of pts achieving at least stable disease. Median (95%CI) DoR was 8.7 (6.2-12.7) months, and median TTR was 2.2 (1.8-3.2) months. Median (95%CI) TTP was 9.9 (5.3-12.0) months, with a median TTF of 5.4 (3.1-9.1) months. The median (95%CI) PFS was 9.6 (5.3-11.5) months, and the median OS was 23.7 (12.0-27.5) months. 14 (54%) pts reported grade 3/4 adverse events (Table). There were no cases of neutropenia, trombopenia or toxic deaths.Table:

553P Incidence of adverse events

Grade 1-2, N (%)Grade 3, N (%)Grade 4, N (%)
Anemia3 (12%)
Paronychia2 (8%)2 (8%)
Rash3 (12%)1 (4%)
Mucositis5 (19%)
Skin toxicity10 (39%)4 (15%)
Diarrhea4 (15%)1 (4%)
Hand-Foot Syndrome1 (4%)2 (8%)
Hypomagnesemia4 (15%)1 (4%)

Conclusions

These preliminary results suggest that panitumumab plus capecitabine is a safe and effective regimen in elderly patients with WT KRAS mCRC.

Clinical trial identification

The number of trial protocol: 2012-000751-13 The realase date (when it was obtained): 2012-06-18

Legal entity responsible for the study

Amgen

Funding

Amgen

Disclosure

All authors have declared no conflicts of interest.

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