Paclitaxel Plus RT Controls Advanced Endometrial Cancer

Pam Harrison

September 16, 2014

Weekly administration of paclitaxel given together with pelvic radiation can adequately control advanced endometrial cancer and reduce pelvic recurrence rates 5 years after undergoing treatment, a phase 2 Korean study suggests.

The study was published in the September issue of the International Journal of Radiation Oncology Biology Physics.

"There is a lack of clear evidence on the best adjuvant treatment plan for patients with advanced endometrial cancer," Jae-Hoon Kim, MD, PhD, coauthor of the study and professor of obstetrics and gynecology, Yonsei University College of Medicine, Seoul, South Korea, said in a statement.

"This study shows that concomitant radiation therapy and weekly paclitaxel chemotherapy is a reasonable treatment option for patients with advanced endometrial cancer that can reduce toxicity and pelvic recurrence."

The study was conducted in 57 patients (aged 36-72 years) with International Federation of Gynecology and Obstetrics (FIGO) stage III or IV endometrial cancer. Twelve patients (21.1%) had FIGO stage IIIA disease; 40 patients (70.1%) had FIGO stage IIIC disease; and 5 patients (8.8%) had FIGO stage IV disease.

The majority of patients had either grade 1 or grade 2 tumors, and slightly more than one quarter had grade 3 tumors.

All patients underwent total abdominal hysterectomy, bilateral salpingo-oophorectomy, pelvic and para-aortic lymphadenectomy, and peritoneal washing cytology.

They then also had radiation and chemotherapy within 6 weeks of surgery.

Patients received a dose of external pelvic radiation totalling of 4500 to 5040 cGy given in 5 fractions a week for 6 weeks. Paclitaxel at a dose of 60 mg/m2 was given intravenously during a 3-hour period once a week, again for 6 weeks.

Mainly Hematologic Toxicity

"Chemotherapy was suspended because of adverse toxic effects in 2 patients," the authors report; 1 patient had septic shock, and the other had grade 4 persistent neutropenia lasting for longer than 2 weeks.

Several other patients withdrew from treatment after enrollment, leaving 52 patients overall who completed the treatment protocol.

Severe toxicity was largely confined to hematologic toxicities. Out of 312 cycles received by these 52 evaluable patients, 11.2% resulted in grade 3 or 4 neutropenia, and 98 cycles were delayed by 1 week because of hematologic toxicity.

The dose of paclitaxel also had to be reduced in 8 patients, or 15.3% overall, because of neutropenia persisting for longer than 1 week.

Overall, however, the novel regimen was well tolerated, with limited nausea as the main nonhematologic toxicity, the authors note.

Survival Data

"Survival data were available for all 52 patients," the authors note.

At 5 years, 82.7% of the group were still alive.

As Dr. Kim told Medscape Medical News, based on historical data, the overall survial (OS) for patients with stage IIIA endometrial cancer is around 67%; for patients with stage IIIC1 disease, OS is around 60%; and for those with stage IIIC2 disease, OS is around 40%.

"A major proportion of our cases were stage IIIC1 and 2," Dr. Kim observed. "So our results are relatively superior."

The estimated disease-free survival rate at 5 years was 63.5%.

All but 1 of the patients who had disease recurrence experienced extrapelvic recurrence; that 1 patient had intrapelvic recurrence in the vaginal vault.

The median time to recurrence was 12 months.

Clear Need for Postoperative Treatment

"Advanced endometrial cancer has a poor long-term prognosis if treated with surgery only," the authors comment in their article. Previous studies have shown that "there is a clear need for postoperative radiation even after adequate surgical staging," Dr. Kim observed, but he added that there is now "growing evidence that chemotherapy should be administered to patients with advanced disease in addition to radiation therapy."

In addition to "the favorable results from this study," he noted that another study has also shown good results from adding radiation and weekly paclitaxel after surgery, although the patients in that study had less advanced disease ( Gynecol Oncol. 2010;116:408-412).

Taken together, the results from these two studies suggest that radiation with concurrent weekly paclitaxel is a reasonable treatment regimen for patients with advanced-stage endometrial cancer, and this approach should be evaluated further, the authors write. Dr. Kim suggested that a large, prospective, randomized controlled study to validate this treatment approach is now needed.

The authors have disclosed no relevant financial relationships.

Int J Radiat Oncol Biol Phys. 2014;90:140-146. Abstract

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