This protocol applies to patients with anaplastic thyroid cancer (ATC) that is unresectable at stage IVB or stage IVC (metastatic), in whom the BRAFV600E mutation is absent — and in whom an initial bridging systemic or radiation-based approach has failed to achieve its primary goals.
Unresectable or metastatic ATC (stage IVB or IVC), confirmed BRAFV600E-negative. The patient is seeking aggressive systemic therapy after prior treatment has not achieved adequate disease regression or airway control.
The previous treatment consisted of early cytotoxic bridging chemotherapy (a taxane and/or an anthracycline, with or without a platinum agent), or in patients with low metastatic burden, radiation therapy with concurrent chemotherapy to maintain airway patency.
That line did not achieve the intended goals of transient disease regression or maintenance of airway patency, prompting escalation to the present protocol.
The next step involves a platinum-containing combination chemotherapy regimen administered on a scheduled cycle basis. The clinical objective is tumor response — partial or complete. Full eligibility criteria, regimen details, sequencing, and monitoring parameters are contained within the structured protocol.
DOI: 10.1089/thy.2020.0944
Among ATC patients with unresectable or advanced disease wishing aggressive therapy, we suggest early initiation of cytotoxic chemotherapy as an initial and potentially bridging approach until mutational interrogation results and/or mutationally specified therapies might be available, and if appropriate.
In BRAF nonmutated patients, radiation therapy with concurrent chemotherapy should be considered in an effort to maintain the airway in patients with low burden of metastatic disease.
However, in a trial conducted by the Eastern Cooperative Oncology Group (293) from 1976 to 1982, 84 patients with advanced progressive thyroid cancer of all histotypes (not specifically ATC) were randomized to receive doxorubicin alone (60 mg/m2 IV every 3 weeks) or doxorubicin plus cisplatin (60 mg/m2 IV doxorubicin, 40 mg/m2 cisplatin IV every 3 weeks).
In 37 patients with ATC on this study, doxorubicin alone produced no CR and 1 PR in 21 treated ATC patients, while doxorubicin plus cisplatin yielded 3 each CR and PR of 18 treated ATC patients (PR+CR: 5% vs. 33%; p < 0.03).
View source ↗