Z Gastroenterol 2010; 48 - P125
DOI: 10.1055/s-0030-1263569

An open-label, multicenter phase II trial of SUNITINIB for patients with chemorefractory metastatic gastric cancer

M Moehler 1, J Hartmann 2, F Lordick 3, S Al-Batran 4, P Reimer 5, S Daum 6, T Trarbach 7, M Ebert 8, C Schimanski 9 P Galle 9, Arbeitsgemeinschaft Internistische Onkologie (AIO)
  • 1Uniklinik Mainz, I. Med. Klinik, Mainz, Germany
  • 2Uniklinik Kiel, Kiel, Germany
  • 3Innere Klinik, Braunschweig, Germany
  • 4Innere Klinik, Frankfurt, Germany
  • 5Innere Klinik, Essen-Sued, Germany
  • 6Uniklinikum Berlin, Berlin, Germany
  • 7Uniklinik Essen, Essen, Germany
  • 8Medizinische Klinik, Klinikum rechts der Isar, Technische Universität München, München, Germany
  • 9Uniklinik Mainz, Mainz, Germany

Aims: Since sunitinib is effective in metastatic renal cancer and GIST tumors, we evaluated tolerability and efficacy of sunitinib for the first time in highly pretreated caucasian patients (pts) with unresectable metastatic (met.) adenocarcinoma of stomach, esophagogastric junction or lower oesophagus.

Methods: 52 caucasian pts were included after documented resistance to 5-FU, cisplatin, oxaliplatin, irinotecan and/or doxetacel. Inclusion criteria were KPS ≥70, measurable lesions and adequate organ functions. Sunitinib was given 50mg/day for 4 weeks with 2 weeks rest (4+2). In case of toxicity, dosage was reduced to 37.5 or 25mg. Treatment continued until progression or non-tolerable side effects. Tumor assessments were performed after cycle 1, 2, 4 etc.

Results: The analysis refers to 51 of 52 pts because 1 pt had no tumor and was thus excluded. Pts (median age 59 years, range 28–81, KPS 90%, gastric 69%, esophagogastric 21%, lower oesophagus 10%) were resistant to median 2 (range 1–6) therapies. Median treatment time was 28 days (range 1–260) and median cycles were 1 (1–6). 38 serious adverse events (SAE) occured in 25 subjects. Thereof 4 SAEs were possibly related assessed to sunitinib (anaemia, vomiting and headache, vomiting, pneumonia, each 1 subject). 1 SAE was judged to be probably related to sunitinib (thrombocytopenia and epistaxis). No SUSAR occurred. The outcome of 12 SAEs was fatal due to progression of disease (10), cholangitis (1) and peritonitis/bacterial sepsis (1). With regard to survival, 9 pts experienced early death (=within 60 days after start of treatment). Among 38 response-evaluable pts, 2 pts had PR and 10 had SD as best reponse. Median PFS was 42 days (CI: 37–60). Due to few omitted tumor assessments PFS may be overestimated. Median OS was 177 days (CI: 106–278). The estimated 1 year survival rate is 23.7% (CI: 12.8–36.6%).

Conclusions: Sunitinib therapy was well tolerated in caucasian patients with highly pretreated chemorefractory gastric cancer. As sunitinib alone was associated with tumor control in some patients, future studies should focus on evaluating the combination of sunitinib with other effective drugs for esophagogastric cancer.