Jejunum free flap in hypopharynx reconstruction: Case series

BACKGROUND: Surgical treatment of hypopharyngeal cancers with extension to the retrocricoid region generally requires a circumferential pharyngolaryngectomy followed by a reconstruction of the removed segment of the upper digestive tract. Historically, many techniques have been used in order to achieve a safe and functional reconstruction. Jejunum interposition is generally considered the best reconstructive technique. METHODS: This study examines the details of the surgical technique, the complications, the oncological and the functional results in a series of 29 consecutive patients submitted to circumferential pharyngoesophageal resection for advanced hypopharyngeal cancer followed by reconstruction with a free flap of jejunum. RESULTS: Three of the transplants failed because of venous thrombosis. The overall success rate was 90%. There were no general complications. A good swallowing has been preserved in all our patients. All our patients where a phonatory prosthesis was positioned (20/29) were able to achieve speech following speech therapy and all were satisfied with their own capacity to communicate. CONCLUSIONS: The prognosis of hypopharyngeal tumours (18–40% at 5 years) remains poor, but jejunum autografts are being shown to be an excellent choice for the reconstruction of the cervical hypopharyngo-oesophagus offering the patient fast rehabilitation and a reasonable quality of survival. Our experience confirm that this kind of reconstruction is safe with a good results in improving oncologic controls and restoring a good quality of life

Phase II study of bevacizumab in combination with docetaxel and radiation in locally advanced squamous cell cancer of the head and neck (SCCHN)

6068 Background: VEGF expression has been shown to be up regulated in SCCHN, representing a promising therapeutic target. Bevacizumab is an anti-VEGF monoclonal antibody that may potentiate the efficacy of concurrent radiation and docetaxel. This trial represents the first attempt, to the best of our knowledge, to establish the efficacy and toxicities of the addition of bevacizumab to concurrent radiation with docetaxel in patients with locally advanced SCCHN. Methods: Patients with previously untreated stage III-IVb SCCHN receive standard once-daily radiation (70.2Gy, 1.8Gy/day), weekly docetaxel (20 mg/m2/week for the duration of radiation) and biweekly bevacizumab (5 mg/kg/two weeks) during and for up to one year following radiation. A total of 30 patients will be enrolled in this study. Results: Twelve of 30 planned patients (11 males), mean age 58 years (range 49–66), all with stage IV disease have been enrolled. Primary site: pharynx (n=8) and larynx (n=4). 10 patients have completed concurrent chemoradiation. After a median followup of 9 months (range: 0 –13), 9 patients remain in complete response, 1 patient developed metastatic disease. 6/10 patients underwent planned neck dissection and they all had a pathologic complete response. 6/9 patients, in complete response, are currently receiving adjuvant bevacizumab. The remaining 3 patients are currently off adjuvant bevacizumab treatment for area of radiation necrosis of larynx (n=1), pharyngoesophageal stenosis (n=1), status post cholecystectomy with pathology revealing acute hemorrhagic cholecystitis with transmural gangrenous necrosis (n=1). Conclusions: For patients with locally advanced SCCHN, preliminary data suggest that the addition of bevacizumab to concurrent radiation with docetaxel is feasible, safe and active. Supported in part by Genentech, NIH grants P30 CA43703 and M01 RR-000080 Clinicaltrials.gov identifier: NCT00281840 [Table: see text] </jats:p

Phase I study of the EGFR tyrosine kinase inhibitor erlotinib in combination with docetaxel and radiation in locally advanced squamous cell cancer of the head and neck (SCCHN)

5545 Background: EGFR is highly expressed in SCCHN, representing a promising therapeutic target. Erlotinib (E) is an EGFR tyrosine kinase inhibitor that may potentiate the efficacy of concurrent radiation (RT) and docetaxel (D). We sought to establish the MTD, toxicities and preliminary efficacy of the combination of RT, D and E in patients (pts) with SCCHN. Methods: Patients with previously untreated stage III-IVB SCCHN were enrolled in a phase I dose-escalating study with standard once-daily RT (70.2 Gy, 1.8 Gy/day), weekly D for the duration of RT and daily E for two weeks prior, during and up to two years following RT. 4 dose levels (DL) were evaluated [D (mg/m2)/E (mg): 15/50, 15/100, 20/100, 20/150]. A 3+3 escalation design was followed. Pharmacokinetic studies (PK) were performed. Results: A total of 23 patients were enrolled (6 pts at each DL 1–3, 5 pts at DL4). Primary site: oral cavity (n = 1), pharynx (n = 15) and larynx (n = 7). 20 patients (87%) had stage IV disease. Three dose-limiting toxicities were observed, 1 at each DL (1–3), including a death within 30 days from last treatment (DL1), grade 3 mucositis resulting in holding RT (&gt;5 days) (DL2) and grade 4 mucositis (DL3). No DLT to date on DL4 with 3/5 pts evaluable. In patients enrolled at DL 1–3 (n = 18), post concurrent chemoRT, best response was CR (n = 15), not evaluable (n = 2), death on study (n = 1). 3/3 pts who underwent planned neck dissection had a pathologic CR. 9 patients are currently receiving adjuvant E and 1 has completed the 2-year course. 3 patients have relapsed. Interpatient variability of E peak plasma concentrations measured after the first dose was observed at all dose levels: 458 ± 173 ng/mL (DL1), 686 ± 364 (DL2), 1017 ± 241 (DL3), 833 ± 222 (DL4) (mean ± s.d., n = 6, 6, 6, 2 at DL1–4 respectively). Adjuvant erlotinib plasma concentration data will be presented separately. No significant PK interaction of erlotinib with docetaxel was noted. Conclusions: The combination of daily erlotinib with weekly docetaxel and RT for pts with stage III-IVB SCCHN is feasible and active. A phase II trial is planned. Supported in part by NIH grants nos. CA62502 and M01 RR-000080. No significant financial relationships to disclose. </jats:p