SPECIAL DEPARTMENTS
Authors: Francesco Graziano, Stefano Cascinu, V. Georgoulias
Journal: Journal of Clinical Oncology (2000)

Article Tools SPECIAL DEPARTMENTS Article Tools OPTIONS & TOOLS Export Citation Track Citation Add To Favorites Rights & Permissions COMPANION ARTICLES No companion articles ARTICLE CITATION DOI: 10.1200/JCO.2000.18.2.445 Journal of Clinical Oncology - published online before print September 21, 2016 PMID: 10637261 Francesco GrazianoxFrancesco GrazianoSearch for articles by this author , Stefano CascinuxStefano CascinuSearch for articles by this author , Italian Group for the Study of Gastrointestinal Tract CarcinomasxSearch for articles by this author V. GeorgouliasxV. GeorgouliasSearch for articles by this author Show More Hospital of UrbinoUrbinoUniversity of MessinaMessina ItalyUniversity General Hospital of Iraklion IraklionCrete, Greece https://doi.org/10.1200/JCO.2000.18.2.445 First Page Full Text PDF Figures and Tables © 2000 by American Society of Clinical OncologyjcoJ Clin OncolJournal of Clinical OncologyJCO0732-183X1527-7755American Society of Clinical OncologyResponse01012000In Reply:We read with great attention Dr Graziano’s and Dr Cascinu’s letter concerning our article, “Treatment of Pancreatic Cancer with Docetaxel and Granulocyte Colony-Stimulating Factor: A Multicenter Phase II Study,” published in the June 1999 issue of the Journal of Clinical Oncology.1We believe several of their remarks are due to a misinterpretation or misunderstanding of the results presented in our article. Indeed, based on the reported data on treatment discontinuation, the authors conclude that no benefit was derived from the treatment for 21 patients. However, this conclusion is arbitrary, because based on standard response evaluation criteria among the 15 patients who stopped treatment, one patient experienced a partial response while two others had stable disease lasting for more than 4 weeks (range, 4 to 23 weeks) after the initial three or six cycles of chemotherapy. Therefore, these three patients cannot be considered as having progressive disease. In addition, their comments on the effect of asthenia and anorexia on patients’ performance status (PS) are confusing because anorexia, which was present in 26 patients (78.7%), is not included in the World Health Organization criteria for PS. Conversely, among the 21 patients with a PS of 1 or 2, 16 patients had a PS of 1 and five patients had a PS of 2, as shown in Table 1. Nowhere in the article was our patient population characterized as having “an excellent performance status.” At the same time, Graziano and Cascinu are surprised because most patients in our study had a good PS. On the basis of the inclusion criteria of the trial, patients with severe organ dysfunction were excluded, which thus allowed patient selection. Indeed, in several phase II trials of pancreatic cancer, the enrolled patients had a good PS (World Health Organization PS of 0 or 1).1,2Graziano and Cascinu considered that there was a discrepancy between the number of patients suffering from pain (n = 21; Table 2) and the number of patients receiving analgesics; 10 patients were receiving narcotics and 17 noncorticosteroidal analgesics; thus, they calculated a total of 27 patients were suffering from pain. However, four patients were receiving only opioids, six patients were receiving a combination of narcotics and nonsteroidal anti-inflammatory drugs, and 11 patients were receiving only nonsteroidal anti-inflammatory drugs (a total of 21 patients). The details on the analgesics consumption were presented to emphasize that only one third of our patients needed opioids for pain relief.Graziano and Cascinu consider that a 36-week median overall survival is probably excessive “because 21 patients worsened during treatment.” This is not accurate, since only 12 patients had progressive disease. The prolonged survival of patients with stable disease is interesting, and a possible explanation is that these patients represent a subgroup with a more favorable tumor biology as compared with patients presenting with progressive disease. Treatment-mediated stable disease associated with tumor growth control may confer a survival benefit in some tumors, eg, the case of irinotecan in patients with advanced colorectal cancer.3 Conversely, disease progression may be indicative of a more aggressive tumor phenotype with rapid tumor development, distant metastases, and short survival. Finally, median survival of untreated pancreatic carcinoma patients has been reported to range from 3.5 to 6.0 months, mostly depending on PS at diagnosis, and this information is given in our article (first paragraph of the Introduction). A prolonged median overall survival has also been observed in other phase II studies. Hidalgo et al2 and Carmichael et al3 have reported survival rates of 10.3 and 6.8 months, respectively. Moreover, in the former study,2 the 1-year survival rate was 39.5%.Our opinion is that the comparison of median survival of patients with progressive disease or stable disease after docetaxel treatment with that of patients treated with gemcitabine may be misleading. In general, conclusions cannot be drawn in oncology by comparing different phase II studies, as Graziano and Cascinu did. However, we agree with them, and this is clearly stated in the Discussion of the article, that additional studies, including randomized trials, are needed to fully determine the place of docetaxel in the treatment of advanced pancreatic cancer. 2. Androulakis N, Kourousis C, Dimopoulos MA, et al: Treatment of pancreatic cancer with docetaxel and granulocyte colony-stimulating factor: A multicenter phase II study. J Clin Oncol 17::1779,1999-1785, Link, Google Scholar2. Hidalgo M, Castellano D, Paz-Ares L, et al: Phase I/II study of gemcitabine and fluorouracil as a continuous infusion in patients with pancreatic cancer. J Clin Oncol 17::585,1999-592, Link, Google Scholar2. Carmichael J, Fink U, Russell R, et al: Phase II study of gemcitabine in patients with advanced pancreatic cancer. Br J Cancer 73::101,1996-105, Crossref, Medline, Google Scholar2. Cunningham D, Pyrhonen S, James RD, et al: Randomized trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet 352::1413,1998-1418, Crossref, Medline, Google Scholar