Two year survival for Concurrent Carboplatin, Paclitaxel, and Hyperfractionated Radiotherapy in Unresectable Head and Neck Cancer.

Reviewer: Tracy d'Entremont, MD
Last Modified: May 31, 2003

Presenter: D. Carter
Presenter's Affiliation: US Oncology, Houston TX
Type of Session: Poster


  • Several randomized trials and meta-analyses have shown superior local control, disease-free and overall survival for simultaneous chemoradiotherapy compared with radiation alone for patients with locally advanced head and neck cancers.
  • Recent evidence also demonstrates the superiority of cisplatin, fluorouracil, and hyperfractionated radiotherapy compared with radiotherapy alone.
  • The optimal choice of cytotoxic agents, radiation dose, and schedule remains to be defined.
  • This study was designed to assess the safety and activity of a combination of carboplatin, paclitaxel and twice-daily radiotherapy in a multicenter, Phase II trial.

Materials and Methods

  • 52 previously untreated patients with Stage III or IV, non-metastatic squamous cell cancers of the head and neck were enrolled.
  • The chemotherapy included Paclitaxel 40 mg/m2/week and Carboplatin AUC=1/week each for 6 doses.
  • Radiotherapy consisted of 120 cGy BID to a total dose of 6960 cGy over 6 weeks.
  • Patients were mostly white males with a performance status of 0 or 1.
  • Median age was 64.3 years.
  • The majority of tumors were >5cm in size.


  • 9 patients were unevaluable: 3 for early death, 3 for withdrawing consent early, 2 for protocol non-compliance and 1 for toxicity.
  • Of the 43 evaluable patients, 72% had a CR, 16% PR 7% SD and 4.6% PD.
  • Grade 3/4 hematologic toxicity was rare 2% for all.
  • The most common grade 3/4 toxicities were dysphagia and mucositis reported in 36% and 34% of patients, respectively.
  • Grade 3/4 dermatologic toxicity was also seen in 34% of patients and Pain was reported in 18% of patients. All other grade 3/4 toxicities were seen in less than 10% of patients.
  • 37% of patients required dose reduction and or delay of both paclitaxel and carboplatin. 20% of patients required dose reduction or delay of the radiation.

Author's Conclusions

    A regimen of twice-daily radiation therapy with concurrent carboplatin and paclitaxel was tolerated in a multi-institutional, community based setting.
  • As expected, mucositis and associated weight loss remained the most common side effects
  • In this high risk group, 2-year progression free survival and overall survival were favorable at 56% and 63% respectively.

Clinical/Scientific Implications

    This study has identified a reasonably well tolerated chemotherapy regimen that can be combined with hyperfractionated radiotherapy in the setting of advanced head and neck cancer. Additional studies evaluating the combination of accelerated radiation regimens with chemotherapy are warranted.

Oncolink's ASCO Coverage made possible by an unrestricted Educational Grant from Bristol-Myers Squibb Oncology.