A randomized phase III study of doxorubicin versus cisplatin/interferon alpha-2b/doxorubicin/fluorouracil (PIAF) combination chemotherapy for unresectable hepatocellular carcinoma.
Winnie Yeo,Tony Mok,Benny Zee,Thomas W.T. Leung,Paul B.S. Lai,Wan Y. Lau,Jane Koh,Frankie Mo,Simon C.H. Yu,Anthony T.C. Chan,Pun Hui,Brigette B.Y. Ma,Kwok Chi Lam,Wing M. Ho,Herman T. Wong,Amanda Tang,Philip J. Johnson +16 more
TLDR
Although patients on PIAF had a higher overall response rate and better survival than patients on doxorubicin, the differences were not statistically significant and the prognosis of patients with unresectable HCC remains poor.Abstract:
Background: Single-agent doxorubicin has been widely used to treat unresectable hepatocellular carcinoma (HCC), but the response rate is low (<20%) and there is no convincing evidence for improved survival. Cisplatin, interferon, doxorubicin, and fluorouracil (PIAF) used in combination, by contrast, has shown promise in a phase II study. We compared doxorubicin to PIAF in patients with unresectable HCC in a phase III trial. Methods: Patients with histologically confirmed unresectable HCC were randomly assigned to receive either doxorubicin or PIAF every 3 weeks, for up to six cycles. The primary endpoint was overall survival, and secondary endpoints were response rate and toxicity. Survival differences were calculated using the Kaplan-Meier method. Treatment groups were compared for differences in the incidence of adverse events using chi-square tests. All statistical tests were two-sided. Results: The median survival of the doxorubicin and PIAF groups was 6.83 months (95% confidence |CI] = 4.80 to 9.56) and 8.67 months (95% CI = 6.36 to 12.00), respectively (P = 0.83). The hazard ratio for death from any cause in the PIAF compared with the doxorubicin groups was 0.97 (95% CI = 0.71 to 1.32). Eighty-six of the 94 patients receiving doxorubicin and 91 of the 94 receiving PIAF were assessable for response. The overall response rates in the doxorubicin and PIAF groups were 10.5% (95% CI = 3.9% to 16.9%) and 20.9% (95% CI = 12.5% to 29.2%), respectively. Neutropenia, thrombocytopenia, and hypokalemia were statistically significantly more common in patients treated with PIAF than in patients treated with doxorubicin. Conclusion: Although patients on PIAF had a higher overall response rate and better survival than patients on doxorubicin, the differences were not statistically significant. PIAF was also associated with increased treatment-related toxicity. The prognosis of patients with unresectable HCC remains poor.read more
Citations
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Journal ArticleDOI
Sorafenib in Advanced Hepatocellular Carcinoma
Josep M. Llovet,Sergio Ricci,Vincenzo Mazzaferro,Philip Hilgard,Edward Gane,Jean-Frédéric Blanc,André Cosme de Oliveira,Armando Santoro,Jean-Luc Raoul,Alejandro Forner,Myron Schwartz,Camillo Porta,Stefan Zeuzem,Luigi Bolondi,Tim F. Greten,Peter R. Galle,Jean Francois Seitz,Ivan Borbath,Dieter Häussinger,Tom Giannaris,Minghua Shan,M. Moscovici,D. Voliotis,Jordi Bruix +23 more
TL;DR: In patients with advanced hepatocellular carcinoma, median survival and the time to radiologic progression were nearly 3 months longer for patients treated with sorafenib than for those given placebo.
Journal ArticleDOI
EASL-EORTC clinical practice guidelines : management of hepatocellular carcinoma
Peter R. Galle,Alejandro Forner,Josep M. Llovet,Vincenzo Mazzaferro,Fabio Piscaglia,Jean-Luc Raoul,Peter Schirmacher,Valérie Vilgrain +7 more
TL;DR: The following Clinical Practice Guidelines will give up-to-date advice for the clinical management of patients with hepatocellular carcinoma, as well as providing an in-depth review of all the relevant data leading to the conclusions herein.
EASL-EORTC Clinical Practice Guidelines: Management of hepatocellular carcinoma European Association for the Study of the Liver ⇑ , European Organisation for Research and Treatment of Cancer
Josep M. Llovet,Michel Ducreux,Riccardo Lencioni,Adrian M. Di Bisceglie,Jean-Francois J. DuFour,Tim F. Greten,Eric Raymond,Tania Roskams,Vincenzo Mazzaferro,Jordi Bruix,Massimo Colombo,Andrew X. Zhu +11 more
TL;DR: The purpose of this document is to assist physicians, patients, health-care providers, and health-policy makers from Europe and worldwide in the decision-making process according to evidencebased data.
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NCCN clinical practice guidelines in oncology: hepatobiliary cancers.
Al B. Benson,Thomas A. Abrams,Edgar Ben-Josef,P. Mark Bloomston,Jean F. Botha,Bryan M. Clary,Anne M. Covey,Steven A. Curley,Michael I. D'Angelica,Rene Davila,William D. Ensminger,John F. Gibbs,Daniel Laheru,Mokenge P. Malafa,Jorge Marrero,Steven G. Meranze,Sean J. Mulvihill,James O. Park,James A. Posey,Jasgit Sachdev,Riad Salem,Elin R. Sigurdson,Constantinos T. Sofocleous,Jean-Nicolas Vauthey,Alan P. Venook,Laura W. Goff,Yun Yen,Andrew X. Zhu +27 more
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Renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up
Bernard Escudier,Camillo Porta,Manuela Schmidinger,Nathalie Rioux-Leclercq,Axel Bex,Vincent Khoo,Vincent Khoo,V. Gruenvald,Alan Horwich +8 more
TL;DR: RCC appears to be more common in patients with obesity, end-stage renal failure, acquired renal cystic disease and tuber-ous sclerosis, and severalautosomal dominant syndromes are described, each with a dis-tinct genetic basis and phenotype.
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