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In Reply

Gabriella Ferrandina, Manuela Ludovisi, Giovanni Scambia

Department of Oncology, Catholic University, Campobasso; Gynecologic Oncology Unit, Catholic University of Rome, Italy

Sandro Pignata

Medical Oncology, National Cancer Institute, Naples, Italy

We greatly appreciated the comments by Dr Abou-Jawde about our article "Phase III Trial of Gemcitabine Compared With Pegylated Liposomal Doxorubicin in Progressive or Recurrent Ovarian Cancer,"¹ although some of his observations seem questionable.

For instance, in his letter Dr Abou-Jawde raises up the issue of having included in our study two different patients’ subgroups, namely the platinum-sensitive and the platinum-resistant ovarian cancer patients (recurring > 6 months and 6 months after the completion of primary treatment, respectively).^2,3 However, it has to be pointed out that in the context of the so-called platinum sensitivity, cases relapsing 6 to 12 months after the last administration of platinum based therapy are considered partially platinum sensitive, which corresponds, as in the case of seeing a glass half full or half empty on the basis of the own view point of each investigator, to partially platinum resistant.⁴ Indeed, the 6- to 12-month time interval from the last platinum administration seems to define a sort of gray zone in terms of platinum responsiveness/resistance, and this is strongly supported by the clinical evidences that, in this subset of patients, the response rates range between 27% and 33% regardless of using a platinum-based rechallenge^2,3,5 or nonplatinum regimen.⁶

Moreover, some clinical and in vitro experiences suggest that the extension of the platinum-free interval through the intercalation of a nonplatinum agent before starting platinum-based regimens at further progression could be of clinical benefit in partially platinum-sensitive recurrent ovarian cancer patients.^7,8

Therefore, in our opinion, the statement by Dr Abou-Jawde that in our trial, "43% of cases were suboptimally treated, and that single-agent gemcitabine or pegylated liposomal doxorubicin (PLD) should not be recommended in partially platinum sensitive patients" should be taken with great caution. Indeed, on the basis of the available data, it has been acknowledged by the United Kingdom National Institute for Health and Clinical Excellence that both platinum-taxane combination or single-agent PLD can be recommended for the treatment of partially platinum-sensitive disease.⁴

Unfortunately, there are currently no data from randomized phase III studies comparing platinum based combinations versus nonplatinum agents in ovarian cancer patients recurring/progressing within 6 to 12 months from last treatment; in this context, the multicentric, randomized phase III trial (MITO-8 study) designed by the Multicenter Italian Trials in Ovarian Cancer (MITO) group to compare carboplatin/paclitaxel versus PLD in partially platinum-sensitive disease, and expected to be launched in the next months, is welcome.

Finally, we appreciated the ultimate comment by Dr Abou-Jawde, who seemed to acknowledge some potential clinical relevance of our work in this field of research.

AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The author(s) indicated no potential conflicts of interest.

ACKNOWLEDGMENTS

Drs Ferrandina, Ludovisi, Scambia, and Pignata are writing on behalf of the Multicenter Italian Trials in Ovarian Cancer Group.

NOTES

published online ahead of print at www.jco.org on April 28, 2008

REFERENCES

1. Ferrandina G, Ludovisi M, Lorusso D, et al: Gemcitabine versus pegylated liposomal doxorubicin in progressive/recurrent ovarian cancer: The Multicenter Italian Trial in Ovarian Cancer (MITO-3) randomized phase III study. J Clin Oncol 26:890-896, 2008[Abstract/Free Full Text]

2. Markman M, Rothman R, Hakes T, et al: Second-line platinum therapy in patients with ovarian cancer previously treated with cisplatin. J Clin Oncol 9:389-393, 1991[Abstract]

3. Markman M, Markman J, Webster K, et al: Duration of response to second-line, platinum-based chemotherapy for ovarian cancer: Implications for patient management and clinical trial design. J Clin Oncol 22:3120-3125, 2004[Abstract/Free Full Text]

4. Colombo N, Gore M: Treatment of recurrent ovarian cancer relapsing 6-12 months post platinum-based chemotherapy. Crit Rev Oncol Hematol 64:129-138, 2007[CrossRef][Medline]

5. Gore M, Fryatt I, Wiltshaw E, Dawson T: Treatment of relapsed carcinoma of the ovary with cisplatin or carboplatin following initial treatment with these components. Gynecol Oncol 36:207-211, 1990[CrossRef][Medline]

6. Cannistra SA: Is there a "best " choice of second-line agent in the treatment of recurrent, potentially platinum sensitive ovarian cancer? J Clin Oncol 20:1158-1160, 2002[Free Full Text]

7. See HT, Freedman RS, Kudelka AP, et al: Retrospective review: Re-treatment of patients with ovarian cancer with carboplatin after platinum resistance. Int J Gynecol Cancer 15:209-216, 2005[CrossRef][Medline]

8. Kavanagh JJ, Tresukosol D, Edwards C, et al: Carboplatin reintroduction after taxane in patients with platinum-refractory epithelial ovarian cancer. J Clin Oncol 13:1584-1588, 1995[Abstract/Free Full Text]

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This Article Full Text (PDF) Erratum (v26,p4697) 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 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 Ferrandina, G. Articles by Pignata, S. Search for Related Content PubMed Articles by Ferrandina, G. Articles by Pignata, S. Social Bookmarking                            What's this?