| General information |
| Database: | DB00376 |
| Objective: | The aim of the study was to evaluate the feasibility and efficacy of adding bevacizumab and erlotinib to concurrent chemoradiation therapy for firstline treatment of patients with locally advanced squamous carcinoma of the head and neck. |
| Authors: | Hainsworth JD, et al |
| Title: | Combined modality treatment with chemotherapy, radiation therapy, bevacizumab, and erlotinib in patients with locally advanced squamous carcinoma of the head and neck: a phase II trial of the Sarah Cannon oncology research consortium. |
| Journal: | Cancer J. |
| Year: | 2011 |
| PMID: | 21952273 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | bevacizumab and erlotinib
|
| Target: | NA
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced head and neck squamous cell carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 3 |
| Therapeutic Combination Content: | induction chemotherapy+radiation therapy+paclitaxel+ bevacizumab+ erlotinib |
| Study Type: | phase II study |
| Key Patients Feature: | All patients were required to have previously untreated, histologically confirmed squamous carcinoma of the head andneck. Primary locations could include the nasopharynx, oralcavity, oropharynx, hypopharynx, or larynx. Patients with metastatic squamous carcinoma involving cervical lymph nodes, without an identified primary site, were also eligible. All patientswere considered to have low cure rates with local therapy alone:(1) nasopharyngeal primary with the exception of T1 N0 M0tumors, (2) clinical evidence of involved cervical lymph nodes(N1, N2, or N3), and (3) any clinical T3 or T4 lesion as determined by computerized tomographic scanning and ENT endoscopy. Additional entry criteria included Eastern CooperativeOncology Group performance status 0 to 1; white blood cellcount, 3500/KL or greater; and platelets, 100, 000/KL or greater;¡¡rum creatinine, 2.0 mg/dL or less; serum bilirubin less than1.5 times the institutional upper limits of normal; measurable orevaluable disease; at least 4 weeks since any major surgicalprocedure. All patients had an indwelling central venous accesscatheter to receive the 5FU infusion. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts received induction chemotherapy with 6 weeks of paclitaxel, carboplatin, infusional 5fluorouracil, and bevacizumab; this treatment was followed by radiation therapy, weekly paclitaxel, bevacizumab, and erlotinib. |
| Primary End Point: | PFS |
| Secondary End Point: | NA |
| Patients Number: | 60 |
| Trial Results |
| DLT_MTD: | grade 3/4 mucosaltoxicity occurred frequently (88%) during combined modality; no unexpectedtoxicity resulted from the addition of bevacizumab and erlotinib |
| Objective Response Rate: | Sixtyfive percent of patients had major responses after inductiontherapy; after completion of therapy, 95% of patients had either partialor complete response radiographically |
| Disease Control Rate: | 0.95 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NR |
| Median OS A vs. C: | NR(not reached) |
| Adverse Event(agent arm): | grade 3/4 mucosal toxicity occurred frequently (88%) during combined modality; no unexpected toxicity resulted from the addition of bevacizumab and erlotinib. |
| Conclusions: | The addition of bevacizumab and erlotinib to firstline combined modality therapy was feasible in a communitybased setting, producing toxicity comparable to other effective combined modality regimens for head and neck cancer. The high level of efficacy suggests that incorporation of these targeted agents into firstline therapy should be further explored. |