This Article Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Berd, D. Articles by Sato, T. Search for Related Content PubMed PubMed Citation Articles by Berd, D. Articles by Sato, T. Related Articles Related Reply Social Bookmarking                            What's this?

Calculation of Survival of Patients With Stage III Melanoma

Division of Hematology-Oncology, Thomas Jefferson University, and AVAX Technologies Inc, Philadelphia, PA

Michael J. Mastrangelo, Takami Sato

Division of Hematology-Oncology, Thomas Jefferson University, Philadelphia, PA

To the Editor:

We wish to comment on the article by Balch et al¹ published in the August 15, 2001, issue of the Journal of Clinical Oncology. We are sending this letter almost 4 years after publication of the article, because we have become aware of a curious feature of the data that escaped our attention previously.

The article analyzed the clinical outcomes of 17,600 melanoma patients in a database compiled from 13 cancer centers and cooperative groups around the world. The results of the analysis formed the basis of a new melanoma staging system that was adopted universally.

What is unusual about the article is the method used for calculating the overall survival times of the patients with stage III melanoma. Whereas virtually all previously published studies used as the starting point the date of documentation of lymph node metastasis (usually the date of lymphadenectomy), Balch et al chose the date of diagnosis of the primary melanoma. The use of an earlier starting point may have affected the authors’ conclusions, upon which the new staging system was based.

The most important of those conclusions was the association of ulceration of the primary lesion with decreased overall survival in patients with stage III disease. At the time of the article’s appearance, this was a striking and unexpected observation. However, it may be explained by the unorthodox method of survival analysis, because ulcerated primaries simply may have resulted in the more rapid development of nodal metastases. One wonders whether the prognostic importance of ulceration in stage III patients would be maintained after recalculation of survival times by the conventional method.

Moreover, by calculating overall survival from the diagnosis of the primary melanoma, the authors substantially increased the survival rates of patients with clinically evident (stage IIIB and IIIC) nodal metastases. For example, in our series of patients with clinical stage IIIB and IIIC disease treated postoperatively with an autologous, hapten-modified vaccine, recalculating the overall survival from the time of diagnosis of the primary increases the 5-year survival substantially: from 44% to 57%.² Because many oncologists use the data of Balch et al as a reference for patient education and as a benchmark for evaluating treatment outcomes, this methodologic difference significantly affects the interpretation of new data.

The statement that the survival of stage III patients was calculated from the time of diagnosis of the primary melanoma is found in at least four places in the article, including one of the figure legends. However, we missed this important point, even after serious study of the article, and an informal survey indicates that it was missed by many of our colleagues in the melanoma community.

Because of the major impact of this article on the way that oncologists think about melanoma biology and treatment, we believe that a reassessment of the results and publication of a revised analysis would be of value at this time.

Authors’ Disclosures of Potential Conflicts of Interest

Although all authors completed the disclosure declaration, the following author or immediate family members 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. For a detailed discription 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.

Authors Employment Leadership Consultant Stock Honoraria Research Funds Testimony Other David Berd AVAX Technologies (N/R) AVAX Technologies (B)

Dollar Amount Codes (A) < $10,000 (B) $10,000–99,000 (C) $100,000 (N/R) Not Required

REFERENCES

1. Balch CM, Soong S-J, Gershenwald JE, et al: Prognostic factors analysis of 17,600 melanoma patients: Validation of the American Joint Committee on Cancer melanoma staging system. J Clin Oncol 19:3622-3634, 2001[Abstract/Free Full Text]

2. Berd D, Sato T, Maguire HC Jr, et al: Immunopharmacological analysis of an autologous, hapten-modified human melanoma vaccine. J Clin Oncol 22:403-415, 2004[Abstract/Free Full Text]

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

Related Reply

• In Reply:
  Charles M. Balch, Seng-Jaw Soong, and Renee Desmond
  JCO 2005 23: 9428 [Full Text]

This Article Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Berd, D. Articles by Sato, T. Search for Related Content PubMed PubMed Citation Articles by Berd, D. Articles by Sato, T. Related Articles Related Reply Social Bookmarking                            What's this?