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Establishment and Characterization of Patient-Derived Xenograft Models of Anaplastic Thyroid Carcinoma and Head and Neck Squamous Cell Carcinoma
Published on: June 2, 2023
The Safety and Efficacy of Weekly Paclitaxel Administration for Anaplastic Thyroid Cancer Patients: A Nationwide
Naoyoshi Onoda1,2, Kiminori Sugino1,3, Takuya Higashiyama1,4
11 Prospective Clinical Study Committee of Anaplastic Thyroid Carcinoma Research Consortium of Japan , Tokyo, Japan .
Background:
Anaplastic thyroid cancer (ATC) is a rare and extremely aggressive malignancy, with a median survival of less than 6 months due to rapid progression and resistance to multimodal therapies. Effective treatment strategies have not been identified. A prospective clinical study was performed to objectively evaluate outcomes of treatment with paclitaxel.
Methods:
An investigator-initiated, multicenter, nonrandomized, open-label, single-arm study to evaluate the feasibility and efficacy of weekly paclitaxel (80 mg/m(2)) administration for patients with pathologically confirmed ATC was conducted in a nationwide organization.
Results:
Feasibility was analyzed in 56 patients. More than one course of treatment was performed in 52 (93%) patients retaining sufficient dose intensity (>84%). No patient had to terminate the treatment because of an adverse event. The median overall survival was 6.7 months [confidence interval 4.4-9.0]. The 6-month survival was 54%. Among the 42 patients with an evaluable lesion, none demonstrated complete remission, 9 (21%) showed partial remission, 22 (52%) achieved stable disease, and 8 (19%) exhibited progressive disease; 3 did not complete the initial treatment course. The objective response rate was 21%, and the clinical benefit rate was 73%. The median time to progression was 1.6 months. Statistically, no additional effect of concomitant radiation was demonstrated in 6 patients receiving combined therapy. Eight patients, in whom a complete post-treatment surgical removal of the tumor was feasible, survived significantly longer (median 7.6 months [CI 8.1-23.0]) than the other 34 patients in whom the tumor could not be completely removed after chemotherapy (5.4 months [CI 3.0-7.8], p = 0.018).
Summary:
The study demonstrates objective and accurate information concerning the feasibility and efficacy of a standardized treatment with weekly paclitaxel administration for ATC patients.
Conclusions:
Weekly paclitaxel administration for ATC patients can be of clinical benefit in a neo-adjuvant setting.
Insights
Weekly paclitaxel shows feasibility and clinical benefit for anaplastic thyroid cancer (ATC) patients. This treatment offers a potential therapeutic option for this aggressive malignancy, improving outcomes in a neo-adjuvant setting.
Area of Science:
- Oncology
- Clinical Therapeutics
Background:
- Anaplastic thyroid cancer (ATC) is a rare, aggressive malignancy with poor prognosis and limited treatment options.
- Rapid progression and resistance to conventional therapies contribute to a median survival of less than six months.
Purpose of the Study:
- To evaluate the feasibility and efficacy of weekly paclitaxel administration in patients with pathologically confirmed ATC.
- To provide objective data on treatment outcomes for this challenging cancer.
Main Methods:
- A prospective, multicenter, nonrandomized, open-label, single-arm study was conducted.
- Weekly paclitaxel at 80 mg/m(2) was administered to patients with confirmed ATC.
- Feasibility, overall survival, objective response rate, and clinical benefit rate were analyzed.
Main Results:
- The treatment was feasible, with 93% of patients completing treatment with sufficient dose intensity and no treatment terminations due to adverse events.
- The median overall survival was 6.7 months, with a 6-month survival rate of 54%.
- The objective response rate was 21%, and the clinical benefit rate was 73%. Patients achieving complete tumor removal post-treatment survived significantly longer.
Conclusions:
- Weekly paclitaxel administration is a feasible and effective treatment for anaplastic thyroid cancer.
- This regimen demonstrates clinical benefit, particularly in a neo-adjuvant setting, offering a promising therapeutic strategy.
