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Journal of Clinical Oncology, Vol 23, No 10 (April 1), 2005: pp. 2436-2437 © 2005 American Society of Clinical Oncology. DOI: 10.1200/JCO.2005.05.266
In Reply:National Cancer Institute, Naples, Italy
Department of Medical Statistics, Second University, Naples, Italy
Department of Medical Oncology, Federico II University; Naples, Italy We read with interest the letter by Altundag et al, looking for further explorative analysis of the Multicenter Italian Trials in Ovarian Cancer (MITO-1) study1 regarding the efficacy of maintenance treatment with topotecan versus observation alone in subgroups based on nadir levels of CA125. Their comment follows a recent presentation of data suggesting that CA125 nadir may have prognostic value also within the range of normality and that the nadir value reached during treatment may be a stronger predictor of prognosis than other commonly considered factors.2 First of all, approximately half of the patients randomly assigned on the MITO-1 study were free of disease (and with normal CA125 levels) after the initial surgical treatment. Thus, reducing the analysis to those patients registered with abnormal values and then responding would dramatically reduce sample size and render any explorative analysis useless. Thus, to meet the request of Altundag et al, we explored whether there was any heterogeneity in the efficacy of topotecan among subgroups built on the CA125 value measured immediately before random assignment at the end of first-line chemotherapy with carboplatin plus paclitaxel. Considering that 87% of the randomly assigned patients were complete responders, it is acceptable that their CA125 values at the end of treatment were at nadir or close to it.
CA125 level was missing in six cases. Overall, 149 patients (55.8%) had CA125 levels
The distribution of patients according to these reported CA125 categories between the topotecan (62.7%, 24.6%, and 12.7% of patients, respectively) and the observation (48.9%, 32.3% and 18.8% of patients, respectively) arms was slightly, though not significantly (P = .07), imbalanced in favor of the topotecan arm according to the hypothesis of Crawford et al.2 Hazard ratios of progression for patients receiving topotecan did not vary significantly according to CA125 levels, as reported in Figure 2.
Thus, the MITO-1 data do not support the hypothesis that CA125 levels after completion of first-line treatment with carboplatin plus paclitaxel can be used to assign patient candidates to maintenance treatment with topotecan, which seems ineffective in all subgroups of patients. Authors' Disclosures of Potential Conflicts of Interest The following authors or their immediate family members have indicated a financial interest. No conflict exists for drugs or devices used in a study if they are not being evaluated as part of the investigation. Honoraria: Sandro Pignata, GlaxoSmithKline. For a detailed description of these 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 of Information for Contributors found in the front of every issue.
REFERENCES
1. De Placido S, Scambia G, Di Vagno G, et al: Topotecan compared with no therapy after response to surgery and carboplatin/paclitaxel in patients with ovarian cancer: Multicenter Italian Trials in Ovarian Cancer (MITO-1) randomized study. J Clin Oncol 22:2635-2642, 2004 2. Crawford SM, Paul J, Reed NS, et al: The prognostic significance of the CA125 nadir in patients that achieve a CA125 response. Proc Am Soc Clin Oncol 22:448, 2004 (abstr 5001)
Related Correspondence
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Copyright © 2005 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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10 U/mL, 76 patients (28.5%) had levels greater than 10 U/mL and 
