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Originally published as JCO Early Release 10.1200/JCO.2009.22.5698 on June 8 2009 © 2009 American Society of Clinical Oncology.
Reply to D.J. Gallagher et alDepartment of Surgical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, TX
Department of Gastrointestinal Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, TX
Department of Surgical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, TX We would like to thank Gallagher et al1 for their interest in our article.2 In our study, 194 (64.6%) of 305 patients received postoperative chemotherapy, and there was no difference in the distribution of these patients among the three groups with complete, major, and minor response (52%, 70%, and 63%, respectively; P = .2). When postoperative chemotherapy was included in a landmark analysis of overall survival, it was not found to be a predictor of overall survival (P = .73; hazard ratio, 0.93; 95% CI, 0.61 to 1.42). For this reason, the variable was not considered further in multivariate analysis. As usual methods lead to biased estimates of survival, we utilized a landmark analysis at 12 weeks after surgery, a time point by which approximately 90% of adjuvant-treated patients had initiated treatment.3 Median survival and 5-year survival for the patients who received adjuvant chemotherapy within 12 weeks of surgery was 55 months and 42%, respectively, versus 52 months and 46%, respectively, for the patients who did not receive adjuvant chemotherapy (Fig 1). In our series, most patients presented with resectable colorectal liver metastases (CLM); these patients typically undergo 2 to 3 months of preoperative chemotherapy followed by 2 to 4 months of postoperative chemotherapy with a total of 6 months of perioperative chemotherapy.4 These data raise the question as to whether postoperative chemotherapy is necessary at all in the treatment of patients with CLM who have received preoperative chemotherapy.
Our study reflects the problematic issue that postoperative chemotherapy cannot always be given to patients, frequently as a result of protracted postoperative recovery. A similar issue emerged in the randomized study by Nordlinger at al,5 where 37% of patients did not receive postoperative chemotherapy in the perioperative chemotherapy arm of the study. In contrast, preoperative chemotherapy can be given consistently to most patients and assists in the selection of patients who most benefit from treatment. Preoperative chemotherapy may also minimize the risk of nontherapeutic laparotomies reported in patients who undergo surgery up front (11% with surgery up front v 5% with perioperative chemotherapy).5 Other data from our group, reporting on the pathologic response to oxaliplatin combined with bevacizumab, suggest that extended chemotherapy (> 4 months) is not more effective than limited chemotherapy.6 In addition, we previously showed an association among irinotecan, steatohepatitis, body mass index, and surgical outcome.7 More recently, we showed that extended preoperative chemotherapy combining oxaliplatin and bevacizumab (ie,  nine cycles) is associated with an increased risk of hepatic insufficiency after resection of CLM.8 Taken together, it is equally important to select preoperative chemotherapy appropriately and to consider the negative effect of protracted chemotherapy. Gallagher et al also refer to a high postoperative mortality but misquote our article, which indicates 3% or 8 deaths (misquoted as 8%) within 60 days. This perioperative mortality is comparable to the perioperative mortality rate (2.8% to 3.1%) reported for hepatic resection of CLM at other major centers that do not advocate the use of preoperative chemotherapy before surgery.9–13 AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST Although all authors completed the disclosure declaration, the following author(s) indicated a financial or other interest that is relevant to the subject matter under consideration in this article. Certain relationships marked with a "U" are those for which no compensation was received; those relationships marked with a "C" were compensated. For a detailed description of the disclosure categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors. Employment or Leadership Position: None Consultant or Advisory Role: Jean-Nicolas Vauthey, sanofi-aventis (C), Genentech (C); Scott Kopetz, Roche (C), sanofi-aventis (C) Stock Ownership: None Honoraria: Jean-Nicolas Vauthey, sanofi-aventis, Genentech; Scott Kopetz, Pfizer; Eddie K. Abdalla, sanofi-aventis Research Funding: Jean-Nicolas Vauthey, sanofi-aventis; Scott Kopetz, Bristol-Myers Squibb, Genentech, Pfizer, BiPar Sciences, Taiho Pharmaceutical; Eddie K. Abdalla, sanofi-aventis Expert Testimony: None Other Remuneration: None REFERENCES
1. Gallagher DJ, Kemeny NE: Colorectal hepatic metastases: Adjuvant chemotherapy and survival. J Clin Oncol 27:e18; 2009. 2. Blazer DG III, Kishi Y, Maru DM, et al: Pathologic response to preoperative chemotherapy: A new outcome end point after resection of hepatic colorectal metastases. J Clin Oncol 26:5344–5351, 2008. 3. Anderson JR, Cain KC, Gelber RD: Analysis of survival by tumor response and other comparisons of time-to-event by outcome variables. J Clin Oncol 26:3913–3915, 2008. 4. Kopetz S, Vauthey JN: Perioperative chemotherapy for resectable hepatic metastases. Lancet 371:963–965, 2008.[CrossRef][Medline] 5. Nordlinger B, Sorbye H, Glimelius B, et al: Perioperative chemotherapy with FOLFOX4 and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC Intergroup trial 40983): A randomised controlled trial. Lancet 371:1007–1016, 2008.[CrossRef][Medline] 6. Ribero D, Wang H, Donadon M, et al: Bevacizumab improves pathologic response and protects against hepatic injury in patients treated with oxaliplatin-based chemotherapy for colorectal liver metastases. Cancer 110:2761–2767, 2007.[CrossRef][Medline] 7. Vauthey JN, Pawlik TM, Ribero D, et al: Chemotherapy regimen predicts steatohepatitis and an increase in 90-day mortality after surgery for hepatic colorectal metastases. J Clin Oncol 24:2065–2072, 2006. 8. Zorzi D, Kishi Y, Maru DM, et al. Extended preoperative chemotherapy does not improve pathologic response and increases postoperative liver insufficiency after hepatic resection for colorectal liver metastases 2009 American Society of Clinical Oncology Gastrointestinal Symposium, Orlando, FL, January 25-27, 2008, abstr 295. 9. Fong Y, Fortner J, Sun RL, et al: Clinical score for predicting recurrence after hepatic resection for metastatic colorectal cancer: Analysis of 1,001 consecutive cases. Ann Surg 230:309–318, 1999.[CrossRef][Medline] 10. Simmonds PC, Primrose JN, Colquitt JL, et al: Surgical resection of hepatic metastases from colorectal cancer: A systematic review of published studies. Br J Cancer 94:982–999, 2006.[CrossRef][Medline] 11. Jarnagin WR, Gonen M, Fong Y, et al: Improvement in perioperative outcome after hepatic resection: Analysis of 1,803 consecutive cases over the past decade. Ann Surg 236:397–406, 2002.[CrossRef][Medline] 12. Virani S, Michaelson JS, Hutter MM, et al: Morbidity and mortality after liver resection: Results of the patient safety in surgery study. J Am Coll Surg 204:1284–1292, 2007.[CrossRef][Medline] 13. Laurent C, Sa Cunha A, Couderc P, et al: Influence of postoperative morbidity on long-term survival following liver resection for colorectal metastases. Br J Surg 90:1131–1136, 2003.[CrossRef][Medline]
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Copyright © 2009 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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