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Paclitaxel may serve as standard treatment for anaplastic thyroid carcinoma
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LAKE BUENA VISTA, Fla. — Weekly paclitaxel may be a feasible standardized chemotherapy regimen for patients with anaplastic thyroid carcinoma, according to prospective study results presented at the International Thyroid Congress.
These data represented the first ever objective outcome report of a potential standard chemotherapy regimen for patients with anaplastic thyroid carcinoma, according to Naoyoshi Onoda, MD, PhD, of the division of surgical oncology at Japan’s Osaka City University Graduate School of Medicine.
“Anaplastic thyroid cancer is very rare,” Onoda said during a presentation. “We do not have any data to establish a standard treatment. We would like to establish some form of standardized treatment, even just one.”
The aggressiveness of anaplastic thyroid carcinoma — coupled with its strong resistance to therapeutic efforts — makes it a difficult disease to treat, according to study background. No standardized effective chemotherapy strategy exists in this disease, which has a median OS of fewer than 6 months.
Thus, Onoda and colleagues conducted a nationwide single-arm, multicenter prospective study in an attempt to identify a safe and effective chemotherapeutic regimen.
Feasibility of treatment served as the primary endpoint. Response rate served as a secondary endpoint.
The researchers assigned 56 patients (median age, 71.3 years; women, n = 40) with pathologically confirmed disease to receive 80 mg/m2 weekly paclitaxel. The most common disease stage in the cohort was IVC (n = 24).
“In Japan, we have less than 100 patients per year that suffer from this disease,” Onoda said. “It was very difficult to enroll even this amount of patients.”
Patients underwent a median of two treatment cycles (range, 0-23).
Overall, 28.6% of patients experienced grade 3 or worse adverse events; however, the researchers did not observe any severe adverse events or treatment-related deaths.
Onoda and colleagues estimated a median OS of 227 days (95% CI, 148.2-305.8). At time of reporting, 11 patients remained alive. Forty-three patients died of anaplastic thyroid cancer, one patient died of other causes and one patient was lost to follow-up.
Thirty-nine patients were evaluable for efficacy. No patients achieved a complete response, whereas nine patients achieved a partial response and 22 patients achieved stable disease.
Eight patients experienced disease progression. The median time to progression was 47 days.
These data equated to an objective response rate of 23.1% and a clinical benefit rate of 79.5%.
Fourteen patients underwent surgical removal of the primary lesion after chemotherapy, which led to nine complete resections and five incomplete resections. These patients survived for a median of 365 days (range, 112-788), prompting the researchers to suggest that surgery in combination with paclitaxel may be beneficial.
“Although short, our OS is a bit longer than what we have had in past reported cases,” Onoda said. “Now that we have objective data about a standardized chemotherapy, this clinical trial demonstrated an objective result for the first time in the world.” – by Cameron Kelsall
Reference:
Onoda N, et al. Short Call Abstract 11. Presented at: International Thyroid Congress; Oct. 18-23, 2015; Lake Buena Vista, Fla.
Disclosure: The researchers report no relevant financial disclosures.