The University of Texas MD Anderson Cancer Center, Houston, TX
Elena Fountzilas , Elangovan Krishnan , Filip Janku , Siqing Fu , Daniel D. Karp , Aung Naing , Vivek Subbiah , David S. Hong , Sarina Anne Piha-Paul , David J Vining , Apostolia Maria Tsimberidou
Background: Hepatic arterial infusion (HAI) of chemotherapy is a treatment option for patients (pts) with cancer metastatic to the liver. We investigated HAI oxaliplatin combined with capecitabine +/- bevacizumab, in advanced cancer with liver involvement. Methods: Pts received HAI oxaliplatin (140 mg/m2) and escalating doses of capecitabine (500, 750, and 1000 mg/m2), with (Arm A) or without (Arm B) bevacizumab (10 mg/kg IV). A 3+3 dose design was used, followed by an expansion phase. Results: From 9/2009 to 2/2014, 61 pts (34 men, 27 women) were enrolled (Arm A = 44; Arm B = 17). Pts were treated in Arm B if they had contraindications to bevacizumab (n = 13) or if there was no spot available in Arm A (n = 4). The median age was 60 yrs (range, 20-88). The most common cancers were colorectal (22 pts), liver (13), pancreas (7), breast (4), and biliary tract (4). The median number of prior therapies was 3 (range, 1-12); 32 (53%) pts had previously oxaliplatin. Grade 3 diarrhea was the only DLT and occurred in 2 pts receiving 1000 mg/m2 capecitabine. Thus, the MTD was HAI oxaliplatin 140 mg/m2, capecitabine 750 mg/m2, and bevacizumab 10 mg/kg. Common toxicities were anemia, thrombocytopenia, neutropenia, hypomagnesemia, and nausea/vomiting. Outcomes are shown in Table. Eleven (18%) pts remained on treatment for ≥6 months, including 4 (6.6%) pts who remained on treatment for ≥1 year. Conclusions: HAI oxaliplatin combined with capecitabine +/- bevacizumab was well-tolerated and was associated with favorable outcomes in selected pts. Clinical trial information: NCT01213238
Oxaliplatin HAI, Capecitabine, Bevacizumab | Oxaliplatin HAI, Capecitabine | Total | |
---|---|---|---|
No. of pts | 44 | 17 | 61 |
No. of evaluable pts | 36 | 11 | 47 |
CR+PR (%) | 8 (22) | 1 (9) | 9 (19) |
SD (%) | 26 (72) | 9 (81) | 35 (75) |
SD≥4 months (%) | 14 (39) | 0 | 14 (30) |
Median TTF, months (95% CI) | 3 (2.27-3.73) | 1.5 (1.0-2.0) | 2.7 (2.4-3.0) |
Median OS, months (95% CI) | 7.1 (5.46-8.8) | 6.2 (3.16-9.17) | 7 (5.57-8.56) |
Median time on Rx, months (95% CI) (Range) | 3 (2.35-3.65) (1-21) | 2 (1.56-2.47) (1-15) | 3 (2.48-3.53) (1-21) |
* CR complete response, OS: overall survival, PR: partial response, Rx: treatment, SD: stable disease, TTF: time to treatment failure
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