Surgery for early metastatic testicular cancer a ‘viable’ treatment option
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Key findings:
- Removal of lymph nodes in the retroperitoneum for early metastatic testicular seminoma resulted in a 2-year RFS rate of 81%.
- The surgical approach spared patients from toxicities of chemotherapy and radiation.
Surgical excision of lymph nodes proved effective as first-line treatment for men with early metastatic testicular seminoma with clinically low-volume retroperitoneal lymphadenopathy, results of the phase 2 SEMS trial showed.
Data published in Journal of Clinical Oncology showed a 100% 2-year OS rate among those who underwent the surgery, suggesting retroperitoneal lymph node dissection may be equally as effective at preventing the spread of metastatic disease but without the long-term toxicities associated with chemotherapy plus radiation, the investigators noted.
“The results are strong, and I believe this approach will be included in national and international guidelines for testicular cancer management in the very near future,” Siamak Daneshmand, MD, professor of urology and director of clinical research at University of Southern California’s Keck School of Medicine, told Healio.
Background
Surgery is not usually considered for early seminomas because chemotherapy and radiation have proved highly effective for the treatment of locally affected lymph nodes in the abdomen, according to Daneshmand. Nevertheless, chemotherapy and radiation carry the potential for long-term side effects that can be spared using surgical excision, he added.
“I suspect no one really explored surgery as an option because early metastatic seminoma is a rarer stage of the disease, but there are enough people out there who could benefit from this approach,” he said. “Seminomas are slower growing and tend to be a little bit more indolent and less metastatic to the chest, so the surgery should be highly effective.”
The novel approach started with four patients who gave informed consent to nonstandard treatment with surgery, all of whom underwent successful procedures leading to cures, Daneshmand noted.
“We were able to spare the side effects of chemotherapy, but we knew that to move the needle forward for this approach we needed to do a larger prospective study, and that’s the multi-institutional phase 2 trial we started in 2016,” he said.
Methodology
The Surgery in Early Metastatic Seminoma (SEMS) trial, a single-arm prospective phase 2 study, examined the safety and efficacy of retroperitoneal lymph node dissection as first-line therapy for men with seminoma and clinically low-volume retroperitoneal adenopathy.
Researchers enrolled 55 men (median age, 34 years; range, 20-64; 80% white; 11% Hispanic) across 12 sites in the United States and Canada with testicular seminoma and isolated retroperitoneal lymphadenopathy ranging from 1 cm to 3 cm.
Twenty-seven patients (49%) had stage I disease with recurrence node size of 1 cm to 2 cm, nine (16%) had stage I disease with node recurrence greater than 2 cm and 17 (31%) had stage IIA disease. The remaining two patients (4%) had stage IIB disease.
Study participants underwent retroperitoneal lymph node dissection that included minimum surgical recommendations of a nerve-sparing, modified ipsilateral template dissection performed by an experienced surgeon.
Two-year recurrence-free survival (RFS) served as the study’s primary endpoint. Secondary endpoints included complication rates, recurrence patterns, use of adjuvant therapies and treatment-free survival.
Median follow-up was 33 months (interquartile range, 12-61.6).
Key findings
Twelve patients (22%) experienced disease recurrence during the study period, for a 2-year RFS rate of 81%.
Among patients who experienced disease relapse, two underwent additional surgery, whereas the remaining 10 received chemotherapy. All 12 patients remained disease free as of their last follow-up, for a 2-year OS rate of 100%.
Four study participants (7%) had short-term surgical complications. Additionally, four patients had long-term complications, including one patient with incisional hernia and three with anejaculation.
Clinical implications
The results of this and similar studies have established surgery as a “viable and attractive treatment option” in the first-line setting for this group of patients, according to Daneshmand.
“We have now treated more than 100 patients with surgery, with highly efficacious results,” he told Healio. “These are the types of results that will end up making their way into clinical guidelines in the very near future as a treatment option for these patients.”
Daneshmand also highlighted outcomes of 16 trial participants found during surgery to have inflamed lymph nodes rather than cancerous ones suspected via a CT scan. He said the choice of a first-line surgery option spared these patients from the toxicities of unnecessary chemotherapy and radiation.
In describing the relevance of the study, Michael A. Carducci, MD, FACP, FASCO, associate editor of Journal of Clinical Oncology, wrote that the results “in total clearly demonstrate that primary [retroperitoneal lymph node dissection] is an option for the management of stage II seminoma with adenopathy < 3 cm given the potential to avoid long-term toxicity of radiation and chemotherapy.”
For more information:
Siamak Daneshmand, MD, can be reached at USC Norris Comprehensive Cancer Center, Department of Urology, 1441 Eastlake Ave., Suite 7416, Los Angeles, CA; e-mail: daneshma@med.usc.edu; Twitter @siadaneshmand.
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