Study Suggests Wider Role for Neoadjuvant Chemo in Ovarian Cancer

ORLANDO – Neoadjuvant chemotherapy with interval debulking surgery yields similar overall and longer progression-free survival when compared with primary debulking surgery for women with stage IV epithelial ovarian cancer, according to a retrospective study.

"Our study suggests a potential wider role for neoadjuvant chemotherapy in management of stage IV ovarian cancer," Dr. Jose Alejandro Rauh-Hain said at the annual meeting of the Society of Gynecologic Oncologists.

Dr. Rauh-Hain and his associates assessed 221 newly diagnosed women with stage IV ovarian cancer. Overall survival was not significantly different at a median of 33 months with neoadjuvant chemotherapy-interval debulking surgery group (NACT-IDS) and 29 months with primary debulking surgery, said Dr. Rauh-Hain, a clinical fellow in obstetrics and gynecology at Massachusetts General Hospital and Brigham and Women’s Hospital, both in Boston.

Median progression-free survival was 14 months for the 45 women in the NACT-IDS group, compared with 10 months among the 176 women treated with primary debulking only.

Patient records were evaluated to subclassify stage IV disease, site of tumor, and dissemination at time of initial diagnosis. All women received primary therapy from Jan. 1, 1995, to Dec. 31, 2007, at either of the two institutions.

The strengths of the study are a large number of patients, treatment based on physician discretion, and an optimal debulking surgery rate of 58%, which is similar to other studies, said invited discussant Dr. Peter Rose. A retrospective design; an unbalanced comparison (because the majority had primary debulking surgery); and a lack of uniform criteria to select neoadjuvant chemotherapy are limitations.

"It seems like we are mixing a lot of different tomatoes, big red ones and small green ones, and what we are getting is tomato sauce," said Dr. Rose, section head, department of obstetrics and gynecology at the Cleveland Clinic in Ohio.

Optimal cytoreduction, defined as residual disease smaller than 1 cm, was not significantly different between groups: 71% of the NACT-IDS and 58% of the primary debulking cohorts (P = .1).

The rate of complete resection to no residual disease was significantly higher among women who underwent NACT-IDS, 27%, vs. 7.5% of women treated with primary debulking (P less than .001).

Median follow-up was 28 months. The longest median overall survival was observed for women who had primary debulking surgery and no residual disease (72 months), but Dr. Rauh-Hain pointed out that "only 7.5% of these patients who underwent primary debulking had no residual disease." This success rate is similar to 8% of 360 women debulked to no residual disease in another report ( J. Clin. Oncol. 2008;26:83-9).

Median overall survival reached 32 months for the primary surgery group who had optimal cytoreduction and to 20 months if cytoreduction was suboptimal.

Dr. Rauh-Hain and his associates also evaluated median progression-free and overall survival rates by site of distant metastatic disease, including pleural effusion, liver, abdomen, distant lymph nodes, and spleen. The only significant difference was in median overall survival among women who had liver metastases and NACT-IDS, 43 months vs. 27 months with primary debulking. Median progression-free survival in this group was 15 months vs. 13 months.

The superior overall survival with NACT-IDS among women who presented with parenchymal liver metastases suggests this therapeutic strategy may be the preferred option for these patients, Dr. Rauh-Hain said.

The NACT-IDS group had a shorter mean length of hospital stay, 8 days vs. 12 days in the primary debulking surgery group. There also was a trend toward fewer postoperative complications in the NACT-IDS cohort, 15% vs. 27%. Also, no woman in the NACT-IDS group died within 30 days of their initial surgery, compared with eight women (5%) of the primary debulking surgery group.

Possible limitations were the retrospective design of the study; lack of information regarding previous or subsequent care at nonaffiliated institutions; and a lack of standardized treatment were possible limitations, Dr. Rauh-Hain said. A lower postoperative mortality rate in the NACT-IDS group suggests there could be selection bias in terms of treatment selection, he added.

Dr. Rauh-Hain said that he had no relevant disclosures. Dr. Rose said he is a member of the Lilly speakers bureau.

ORLANDO – Neoadjuvant chemotherapy with interval debulking surgery yields similar overall and longer progression-free survival when compared with primary debulking surgery for women with stage IV epithelial ovarian cancer, according to a retrospective study.

"Our study suggests a potential wider role for neoadjuvant chemotherapy in management of stage IV ovarian cancer," Dr. Jose Alejandro Rauh-Hain said at the annual meeting of the Society of Gynecologic Oncologists.

Dr. Rauh-Hain and his associates assessed 221 newly diagnosed women with stage IV ovarian cancer. Overall survival was not significantly different at a median of 33 months with neoadjuvant chemotherapy-interval debulking surgery group (NACT-IDS) and 29 months with primary debulking surgery, said Dr. Rauh-Hain, a clinical fellow in obstetrics and gynecology at Massachusetts General Hospital and Brigham and Women’s Hospital, both in Boston.

Median progression-free survival was 14 months for the 45 women in the NACT-IDS group, compared with 10 months among the 176 women treated with primary debulking only.

Patient records were evaluated to subclassify stage IV disease, site of tumor, and dissemination at time of initial diagnosis. All women received primary therapy from Jan. 1, 1995, to Dec. 31, 2007, at either of the two institutions.

The strengths of the study are a large number of patients, treatment based on physician discretion, and an optimal debulking surgery rate of 58%, which is similar to other studies, said invited discussant Dr. Peter Rose. A retrospective design; an unbalanced comparison (because the majority had primary debulking surgery); and a lack of uniform criteria to select neoadjuvant chemotherapy are limitations.

"It seems like we are mixing a lot of different tomatoes, big red ones and small green ones, and what we are getting is tomato sauce," said Dr. Rose, section head, department of obstetrics and gynecology at the Cleveland Clinic in Ohio.

Optimal cytoreduction, defined as residual disease smaller than 1 cm, was not significantly different between groups: 71% of the NACT-IDS and 58% of the primary debulking cohorts (P = .1).

The rate of complete resection to no residual disease was significantly higher among women who underwent NACT-IDS, 27%, vs. 7.5% of women treated with primary debulking (P less than .001).

Median follow-up was 28 months. The longest median overall survival was observed for women who had primary debulking surgery and no residual disease (72 months), but Dr. Rauh-Hain pointed out that "only 7.5% of these patients who underwent primary debulking had no residual disease." This success rate is similar to 8% of 360 women debulked to no residual disease in another report ( J. Clin. Oncol. 2008;26:83-9).

Median overall survival reached 32 months for the primary surgery group who had optimal cytoreduction and to 20 months if cytoreduction was suboptimal.

Dr. Rauh-Hain and his associates also evaluated median progression-free and overall survival rates by site of distant metastatic disease, including pleural effusion, liver, abdomen, distant lymph nodes, and spleen. The only significant difference was in median overall survival among women who had liver metastases and NACT-IDS, 43 months vs. 27 months with primary debulking. Median progression-free survival in this group was 15 months vs. 13 months.

The superior overall survival with NACT-IDS among women who presented with parenchymal liver metastases suggests this therapeutic strategy may be the preferred option for these patients, Dr. Rauh-Hain said.

The NACT-IDS group had a shorter mean length of hospital stay, 8 days vs. 12 days in the primary debulking surgery group. There also was a trend toward fewer postoperative complications in the NACT-IDS cohort, 15% vs. 27%. Also, no woman in the NACT-IDS group died within 30 days of their initial surgery, compared with eight women (5%) of the primary debulking surgery group.

Possible limitations were the retrospective design of the study; lack of information regarding previous or subsequent care at nonaffiliated institutions; and a lack of standardized treatment were possible limitations, Dr. Rauh-Hain said. A lower postoperative mortality rate in the NACT-IDS group suggests there could be selection bias in terms of treatment selection, he added.

Dr. Rauh-Hain said that he had no relevant disclosures. Dr. Rose said he is a member of the Lilly speakers bureau.

ORLANDO – Neoadjuvant chemotherapy with interval debulking surgery yields similar overall and longer progression-free survival when compared with primary debulking surgery for women with stage IV epithelial ovarian cancer, according to a retrospective study.

"Our study suggests a potential wider role for neoadjuvant chemotherapy in management of stage IV ovarian cancer," Dr. Jose Alejandro Rauh-Hain said at the annual meeting of the Society of Gynecologic Oncologists.

Dr. Rauh-Hain and his associates assessed 221 newly diagnosed women with stage IV ovarian cancer. Overall survival was not significantly different at a median of 33 months with neoadjuvant chemotherapy-interval debulking surgery group (NACT-IDS) and 29 months with primary debulking surgery, said Dr. Rauh-Hain, a clinical fellow in obstetrics and gynecology at Massachusetts General Hospital and Brigham and Women’s Hospital, both in Boston.

Median progression-free survival was 14 months for the 45 women in the NACT-IDS group, compared with 10 months among the 176 women treated with primary debulking only.

Patient records were evaluated to subclassify stage IV disease, site of tumor, and dissemination at time of initial diagnosis. All women received primary therapy from Jan. 1, 1995, to Dec. 31, 2007, at either of the two institutions.

The strengths of the study are a large number of patients, treatment based on physician discretion, and an optimal debulking surgery rate of 58%, which is similar to other studies, said invited discussant Dr. Peter Rose. A retrospective design; an unbalanced comparison (because the majority had primary debulking surgery); and a lack of uniform criteria to select neoadjuvant chemotherapy are limitations.

"It seems like we are mixing a lot of different tomatoes, big red ones and small green ones, and what we are getting is tomato sauce," said Dr. Rose, section head, department of obstetrics and gynecology at the Cleveland Clinic in Ohio.

Optimal cytoreduction, defined as residual disease smaller than 1 cm, was not significantly different between groups: 71% of the NACT-IDS and 58% of the primary debulking cohorts (P = .1).

The rate of complete resection to no residual disease was significantly higher among women who underwent NACT-IDS, 27%, vs. 7.5% of women treated with primary debulking (P less than .001).

Median follow-up was 28 months. The longest median overall survival was observed for women who had primary debulking surgery and no residual disease (72 months), but Dr. Rauh-Hain pointed out that "only 7.5% of these patients who underwent primary debulking had no residual disease." This success rate is similar to 8% of 360 women debulked to no residual disease in another report ( J. Clin. Oncol. 2008;26:83-9).

Median overall survival reached 32 months for the primary surgery group who had optimal cytoreduction and to 20 months if cytoreduction was suboptimal.

Dr. Rauh-Hain and his associates also evaluated median progression-free and overall survival rates by site of distant metastatic disease, including pleural effusion, liver, abdomen, distant lymph nodes, and spleen. The only significant difference was in median overall survival among women who had liver metastases and NACT-IDS, 43 months vs. 27 months with primary debulking. Median progression-free survival in this group was 15 months vs. 13 months.

The superior overall survival with NACT-IDS among women who presented with parenchymal liver metastases suggests this therapeutic strategy may be the preferred option for these patients, Dr. Rauh-Hain said.

The NACT-IDS group had a shorter mean length of hospital stay, 8 days vs. 12 days in the primary debulking surgery group. There also was a trend toward fewer postoperative complications in the NACT-IDS cohort, 15% vs. 27%. Also, no woman in the NACT-IDS group died within 30 days of their initial surgery, compared with eight women (5%) of the primary debulking surgery group.

Possible limitations were the retrospective design of the study; lack of information regarding previous or subsequent care at nonaffiliated institutions; and a lack of standardized treatment were possible limitations, Dr. Rauh-Hain said. A lower postoperative mortality rate in the NACT-IDS group suggests there could be selection bias in terms of treatment selection, he added.

Dr. Rauh-Hain said that he had no relevant disclosures. Dr. Rose said he is a member of the Lilly speakers bureau.