In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. e15136-e15136
Abstract:
e15136 Background: S is the currently approved treatment for HCC. C has antitumor activity in HCC and biliary tree cancers. The combination of the two, if tolerated, could possibly improve antitumor response, and patient-overall survival (OS). Methods: This phase II trial of S and C accrued unresectable HCC pts. with histologically confirmed disease or radiological characteristics of HCC in cirrhotics with an elevated AFP of 〉 400 ng/mL. Eligibility criteria were: ECOG Performance status of ≤ 2, Child-Pugh (CP) class A or B-7 cirrhosis, hemoglobin ≥ 8.5 g/dL, platelets ≥ 50,000/µL, ANC ≥ 1500 cells/µL, and a serum creatinine of ≤ 2.0 mg/dL (creatinine clearance 〉 30 mL/minute). HIV+ patients were excluded. All subjects received a combination of S and C, on a 14-day treatment schedule. S dose was started at 400 mg BID daily with dose adjustments for hand foot syndrome. Starting C dose was 850 mg/m 2 BID for 7 days and a 7-day break; doses were adjusted as tolerated. The primary end point was assessment of safety and tolerability. OS and disease control rate (DCR) were also estimated. Results: 15/47 assessed pts. met inclusion criteria. One patient was never treated and excluded from analysis. Response data were available on 13 and safety data on all 14. Median pts.’ age was 64 years (56-79), and 75 % were male. Etiologies included viral hepatitis (64%), or viral hepatitis and alcohol in another 29%; 50% of pts. had CP class A (5-6) and 50% B-7 cirrhosis. With a median follow up of 12 months (M), median OS (mOS) was 11.3 (95% CI, 2.7-21.3) M. DCR was 54% (CR 8%, PR 15% and SD 31%). Grade 3-4 adverse events included: thrombocytopenia 9(64%), neutropenia 1(7%), anemia 2(14%); electrolyte imbalance, hypophosphatemia 3(21%), hypomagnesemia 2(14%), hypocalcaemia 1 and hyponatremia 1 (7%) each. Liver abnormalities included; hyperbilirubinemia 3(21%), increased AST 2(14%). Skin and mucosal abnormalities included hand-foot syndrome 3(21%), mucositis 1, alopecia 1 and skin rash 1 each. DVT occurred in 3 (21%). Conclusions: At tolerable doses, S and C seem active and safe palliative treatment for HCC in CP A & B-7 cirrhotics. It was associated with a DCR of 54% and mOS of 11.3 M. The small sample size does not allow comparison with single agent S. Clinical trial information: NCT01032850.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2013.31.15_suppl.e15136
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2013
detail.hit.zdb_id:
2005181-5
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