Phase II trial tests induction chemo with carboplatin, paclitaxel, lapatinib before transoral surgery in SCCHN

This single-arm, non-randomized, two-stage phase II trial investigated a multimodality, risk-adapted treatment approach for previously untreated patients with squamous cell carcinoma of the head and neck (SCCHN) arising in the oral cavity, oropharynx, or supraglottic larynx that was amenable to a transoral surgical approach. The study enrolled 40 patients. Treatment consisted of three parts: Part 1 was neoadjuvant induction with weekly carboplatin and paclitaxel in combination with daily lapatinib for 6 weeks. Part 2 was transoral surgery. Part 3 was postoperative treatment adapted to the patient's risk category following surgery. Low-risk patients received no further treatment or involved field radiation only. Medium-risk patients received ipsilateral radiation concurrent with weekly chemotherapy. High-risk patients received cisplatin every 3 weeks and daily lapatinib concurrent with bilateral radiation. The primary outcome measure was overall response rate. The study was conducted by the UNC Lineberger Comprehensive Cancer Center, started in June 2012, reached primary completion in November 2016, and results were posted on October 13, 2017. The abstract does not report specific efficacy results, safety data, or statistical outcomes for the primary or any secondary endpoints.

Imagine facing a head and neck cancer diagnosis and worrying about the harsh side effects of treatment. A study asked if a gentler, more personalized approach could help. They tested a three-part plan for people with a specific type of head and neck cancer that could be treated with a less invasive surgery. First, patients received six weeks of chemotherapy with two drugs (carboplatin and paclitaxel) plus a daily pill called lapatinib. Then, they had surgery through the mouth. Finally, the treatment plan was tailored based on what was found during surgery. If the cancer was low risk, patients got no further treatment or just radiation to a small area. For medium risk, they got radiation to one side of the neck with weekly chemo. For high risk, they got a stronger chemo drug (cisplatin) every three weeks along with daily lapatinib, plus radiation to both sides of the neck. The main goal was to see how well patients responded overall. The study involved 40 people and was completed to see if this risk-adapted method could lessen toxic effects and improve treatment.