- Email: [email protected]
“Importance of delivered cycles and nomogram for intraperitoneal chemotherapy in ovarian cancer”
390
Letters to the Editor
We agree that the rate of vaginal cuff dehiscence was slightly higher than the rate reported by other authors [5] for minimally invasive approaches, but it has improved significantly (about 1% in the past 12 months) after we changed our closure technique (data submitted for publication). We agree as well about the high recurrence rate reported in the study but it has to be pointed out that the patients who recurred presented significant risk factors such as locally advanced stage treated with neoadjuvant chemotherapy lymph nodes metastasis and rare histology types characterized by poor prognosis. Unfortunately “negative margins” in Table 3 is, in fact, a mistake and we apologize about it. The discrepancy between the stages included and the range of tumor diameter in the final pathology findings is justified by the fact that those patients whose tumor diameter was larger than 4 cm received neoadjuvant chemotherapy (14 pts in abdominal radical hysterectomy (ARH) group and 9 in RRH one). The measurements reported in Table 3 reflect the final pathology results and therefore the effects of chemotherapy on tumor volume. Obviously, the stage was not changed being cervical cancer clinically staged following FIGO criteria. The last comment is about the longer surgical time reported in the study compared with the one we presented as our preliminary data [6]. First of all, the difference is not statistically significant (272 vs. 260 min) and therefore clinically irrelevant, but moreover there are significant differences between the two groups of patients since our preliminary report was on 11 stage IB1 cervical cancer patients and none of them had received neoadjuvant chemotherapy. It has been our observation that surgical treatment after neoadjuvant chemotherapy can be more difficult and time consuming due to easy bleeding and not easily identifiable surgical planes. We would like to point out as well that 40% of our RRH were type C1 radical hysterectomy as defined by the recently new proposed classification of Querleu and Morrow [7] comparable to type III of Piverclassification but including nerve-sparing procedure that requires, as it is well known, a longer operative time to be accomplished. We would like to thank Dr. Sert again for his interesting and thoughtful review of our paper. Conflict of interest statement The authors declare that there are no conflicts of interest.
References [1] Sert BM. Robotic-assisted laparoscopic radical hysterectomy (Piver type III) with pelvic node dissection—case report. Eur J Gynaecol Oncol 2006;27(5):531–3. [2] Maggioni A, et al. Robotic approach for cervical cancer: comparison with laparotomy: a case control study. Gynecol Oncol 2009;115:60–4. [3] Abu- Rustum NR, et al. Total laparoscopic radical hysterectomy with pelvic lymphadenectomy using the argon-beam coagulator: pilot data and comparison to laparotomy. Gynecol Oncol 2003;91:402–9. [4] Obermair A. A phase III randomized clinical trial comparing laparoscopic or robotic radical hysterectomy in patients with early stage cervical cancer. J Minim Invasiv Gynecol 2008;15(5):584–8. [5] Kho RM, et al. Incidence and characteristics of patients with vaginal cuff dehiscence after robotic procedures. Obstet Gynecol 2009 Aug;114(2 Pt 1):231–5. [6] Bocciolone L, et al. Robotic modified radical hysterectomy with pelvic lymph-node dissection: Preliminary 93 results of a novel technique for early stage cervical cancer. MIRA 2008 3rd international congress, January 24th–26th, 2008. Rome, Italy. Abstract book p:190. [7] Querleu D, et al. Classification of radical hysterectomy. Lancet Oncol 2008 Mar;9(3): 297–303.
Lucas Minig Gynecology Department, European Institute of Oncology, Milan, Italy Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, USA E-mail address: [email protected]. Corresponding author. Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bldg 10 B3B69C, Bethesda, MD 20892, USA. Fax: +1 301 480 5439.
Vanna Zanagnolo Angelo Maggioni Gynecology Department, European Institute of Oncology, Milan, Italy 15 January 2010 doi:10.1016/j.ygyno.2010.01.033
“Importance of delivered cycles and nomogram for intraperitoneal chemotherapy in ovarian cancer”
To the Editor: Yen, et al, in a recent issue of Gynecologic Oncology describe the development of a “nomogram” to assist clinicians in their decision-making regarding the use of intraperitoneal (IP) chemotherapy in women with advanced ovarian cancer [1]. While conceptually such efforts may be of considerable value a particular conclusion of this analysis must be vigorously challenged. Based on their retrospective review of patients treated in a randomized trial that compared IP to intravenous chemotherapy the investigators conclude that “at least five IP cycles are needed to achieve better survival” [1]. As patients entered into this trial were not randomized to a particular number of IP cycles, the apparent superior outcome associated with the delivery of “at least five IP cycles” may simply have been due to the well-recognized observation that patients who are not progressing during treatment are highly likely to be able to receive more treatment cycles. Further, even if the investigators were unable to definitively document progression, subtle changes (decreased appetite, increased fatigue, treatment-related abdominal pain) that were classified as “toxicity” may (in fact) have been due to unappreciated disease progression. Thus, while a greater number of treatment cycles may have been found to be “statistically” correlated with better survival, the mere ability to receive a greater number of IP cycles (“at least 5”) may have been the result of a favorable outcome, and not the direct cause. Ultimately, if a phase 3 trial is ever conducted that specifically addresses the issue of the importance of the number of IP treatment cycles, the investigators may be found to be correct in their assertion. However, the available data from this (or any other reported trial) do not permit such a statement to be made with any acceptable level of objective scientific validity. Conflict of interest statement The author has not conflicts of interest related to the material included in this manuscript.
Reference [1] Yen M-S, Twu N-F, Lai C-R, Horng H-C, Chao K-C, Juang C-M. Importance of delivered cycles and nomogram for intraperitoneal chemotherapy in ovarian cancer. Gynecol Oncol 2009;114:415–9.
Maurie Markman Department of Gynecologic Medical Oncology, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030, USA E-mail address: [email protected]. Fax: +1 713 563 9586. 16 December 2009 doi:10.1016/j.ygyno.2010.01.005
Letters to the Editor
We agree that the rate of vaginal cuff dehiscence was slightly higher than the rate reported by other authors [5] for minimally invasive approaches, but it has improved significantly (about 1% in the past 12 months) after we changed our closure technique (data submitted for publication). We agree as well about the high recurrence rate reported in the study but it has to be pointed out that the patients who recurred presented significant risk factors such as locally advanced stage treated with neoadjuvant chemotherapy lymph nodes metastasis and rare histology types characterized by poor prognosis. Unfortunately “negative margins” in Table 3 is, in fact, a mistake and we apologize about it. The discrepancy between the stages included and the range of tumor diameter in the final pathology findings is justified by the fact that those patients whose tumor diameter was larger than 4 cm received neoadjuvant chemotherapy (14 pts in abdominal radical hysterectomy (ARH) group and 9 in RRH one). The measurements reported in Table 3 reflect the final pathology results and therefore the effects of chemotherapy on tumor volume. Obviously, the stage was not changed being cervical cancer clinically staged following FIGO criteria. The last comment is about the longer surgical time reported in the study compared with the one we presented as our preliminary data [6]. First of all, the difference is not statistically significant (272 vs. 260 min) and therefore clinically irrelevant, but moreover there are significant differences between the two groups of patients since our preliminary report was on 11 stage IB1 cervical cancer patients and none of them had received neoadjuvant chemotherapy. It has been our observation that surgical treatment after neoadjuvant chemotherapy can be more difficult and time consuming due to easy bleeding and not easily identifiable surgical planes. We would like to point out as well that 40% of our RRH were type C1 radical hysterectomy as defined by the recently new proposed classification of Querleu and Morrow [7] comparable to type III of Piverclassification but including nerve-sparing procedure that requires, as it is well known, a longer operative time to be accomplished. We would like to thank Dr. Sert again for his interesting and thoughtful review of our paper. Conflict of interest statement The authors declare that there are no conflicts of interest.
References [1] Sert BM. Robotic-assisted laparoscopic radical hysterectomy (Piver type III) with pelvic node dissection—case report. Eur J Gynaecol Oncol 2006;27(5):531–3. [2] Maggioni A, et al. Robotic approach for cervical cancer: comparison with laparotomy: a case control study. Gynecol Oncol 2009;115:60–4. [3] Abu- Rustum NR, et al. Total laparoscopic radical hysterectomy with pelvic lymphadenectomy using the argon-beam coagulator: pilot data and comparison to laparotomy. Gynecol Oncol 2003;91:402–9. [4] Obermair A. A phase III randomized clinical trial comparing laparoscopic or robotic radical hysterectomy in patients with early stage cervical cancer. J Minim Invasiv Gynecol 2008;15(5):584–8. [5] Kho RM, et al. Incidence and characteristics of patients with vaginal cuff dehiscence after robotic procedures. Obstet Gynecol 2009 Aug;114(2 Pt 1):231–5. [6] Bocciolone L, et al. Robotic modified radical hysterectomy with pelvic lymph-node dissection: Preliminary 93 results of a novel technique for early stage cervical cancer. MIRA 2008 3rd international congress, January 24th–26th, 2008. Rome, Italy. Abstract book p:190. [7] Querleu D, et al. Classification of radical hysterectomy. Lancet Oncol 2008 Mar;9(3): 297–303.
Lucas Minig Gynecology Department, European Institute of Oncology, Milan, Italy Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, USA E-mail address: [email protected]. Corresponding author. Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bldg 10 B3B69C, Bethesda, MD 20892, USA. Fax: +1 301 480 5439.
Vanna Zanagnolo Angelo Maggioni Gynecology Department, European Institute of Oncology, Milan, Italy 15 January 2010 doi:10.1016/j.ygyno.2010.01.033
“Importance of delivered cycles and nomogram for intraperitoneal chemotherapy in ovarian cancer”
To the Editor: Yen, et al, in a recent issue of Gynecologic Oncology describe the development of a “nomogram” to assist clinicians in their decision-making regarding the use of intraperitoneal (IP) chemotherapy in women with advanced ovarian cancer [1]. While conceptually such efforts may be of considerable value a particular conclusion of this analysis must be vigorously challenged. Based on their retrospective review of patients treated in a randomized trial that compared IP to intravenous chemotherapy the investigators conclude that “at least five IP cycles are needed to achieve better survival” [1]. As patients entered into this trial were not randomized to a particular number of IP cycles, the apparent superior outcome associated with the delivery of “at least five IP cycles” may simply have been due to the well-recognized observation that patients who are not progressing during treatment are highly likely to be able to receive more treatment cycles. Further, even if the investigators were unable to definitively document progression, subtle changes (decreased appetite, increased fatigue, treatment-related abdominal pain) that were classified as “toxicity” may (in fact) have been due to unappreciated disease progression. Thus, while a greater number of treatment cycles may have been found to be “statistically” correlated with better survival, the mere ability to receive a greater number of IP cycles (“at least 5”) may have been the result of a favorable outcome, and not the direct cause. Ultimately, if a phase 3 trial is ever conducted that specifically addresses the issue of the importance of the number of IP treatment cycles, the investigators may be found to be correct in their assertion. However, the available data from this (or any other reported trial) do not permit such a statement to be made with any acceptable level of objective scientific validity. Conflict of interest statement The author has not conflicts of interest related to the material included in this manuscript.
Reference [1] Yen M-S, Twu N-F, Lai C-R, Horng H-C, Chao K-C, Juang C-M. Importance of delivered cycles and nomogram for intraperitoneal chemotherapy in ovarian cancer. Gynecol Oncol 2009;114:415–9.
Maurie Markman Department of Gynecologic Medical Oncology, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030, USA E-mail address: [email protected]. Fax: +1 713 563 9586. 16 December 2009 doi:10.1016/j.ygyno.2010.01.005