To demonstrate that the 3 reconstructive advantages of the thoracodorsal artery scapular tip transplant (Tdast), a long pedicle, independently mobile tissue components, and the 3-dimensional nature ...of the scapular tip, will improve the quality and success of complex reconstructions by avoiding vein grafting, preventing the need for 2 separate transplants, and facilitating bony inset.
Prospective case series.
Tertiary care academic medical center.
Twenty-one patients (male to female ratio, 16:5; mean age, 52 years) underwent reconstruction of the upper, middle, and lower face from 2001 through 2006. Indications for reconstruction were tumor ablation in 11 patients, secondary reconstruction in 4 patients, osteoradionecrosis in 4, and posttraumatic reconstruction in 2. Seventeen patients underwent radiation.
All patients underwent harvest of an autogenous transplant of scapular tip bone and latissimus dorsi soft tissue based on the thoracodorsal artery. The mean bone length was 5.2 cm (range, 2.5-9.0 cm), and the mean cutaneous surface area was 68 cm² (range, 20-250 cm²).
Reduction of vein grafting, avoidance of 2 transplants, use of the triangular shape of the scapular tip in reconstruction, complications, and shoulder function.
The success rate of transplantation was 100%. The use of this transplant avoided vein grafting in 16 patients and the need for 2 separate transplants in 11 patients, and the 3-dimensional nature of the scapular tip facilitated inset in 13 patients. In 14 patients, more than 1 of these reconstructive advantages was achieved. In 6 patients, all 3 were accomplished. Eleven patients experienced a complication. The major complication rate was 33%, and the minor complication rate was 33%. The mean Constant-Murley test of shoulder function score was 87 of 100 (range, 74-100).
The Tdast is an excellent choice for reconstruction in the head and neck as an alternative to procedures requiring vein grafting and multiple free tissue transplants, or in which the 3-dimensional contour of the scapular tip aids in reconstruction. The complication rate should be assessed in the context of the risk factors of the patient population and the outcome with respect to stable employment, increasing body mass index, and maintenance of shoulder function.
To determine if oropharyngoplasty using a Gehanno technique of superior constrictor velopharyngoplasty, base of tongue mounding, and primary hypopharyngeal closure in combination with template-based ...revascularized free tissue transfer is effective for reconstruction of the oropharyngeal defect.
Prospective case series.
Tertiary care academic medical center.
The study population comprised 25 patients (21 men and 4 women; mean age, 55.3 years) presenting from January 1998 to January 2001 with oropharyngeal squamous cell carcinoma. A comparison was performed based on the percentage of resection of the soft palate (group 1, < or =50% palate; group 2, >50% palate).
Of the 25 patients, 24 (96%) received radiotherapy. The donor sites were radial forearm for 23 of 25 patients (92%) and lateral arm for 2 of 25 patients (8%). The mean area was 92 cm(2) (range, 25-150 cm(2)), and the mean length of the velopharyngoplasty component of the oropharyngoplasty was 2.15 cm (range, 1-3 cm).
Gastrostomy tube dependence, major and minor complications, time to oral intake, speech and swallowing assessment, and quality-of-life assessment.
Of the 25 patients, 2 (8%) remain gastrostomy dependent; 6 (24%) developed major complications; and 7 (28%) developed minor complications. Speech in both groups 1 and 2 was considered understandable most of the time, with occasional repetition. The group 1 patient with a median assessment score could eat a solid diet without restriction of place or person, whereas the group 2 patient with a median assessment score could eat a soft, moist diet with selected persons in selected places.
Integration of oropharyngoplasty with template-based revascularized free tissue transfer produced speech results that were independent of palate defect size, and swallow function test results were similar to other published reconstructive techniques.
To determine if a rectangular template free tissue transfer is effective for the reconstruction of the hemiglossectomy defect.
Prospective case series.
Tertiary care academic medical center.
A total ...of 13 patients (male to female ratio, 8:5; mean age, 55 years) presenting with squamous cell carcinoma of the oral tongue from May 2000 to December 2002.
Of the 13 patients, 7 received postoperative radiotherapy and 2 received prior radiotherapy. The radial forearm was the donor site in 11 patients and the lateral arm and anterolateral thigh in 1 patient each. The mean flap area was 50 cm(2) (range, 24-80 cm(2)).
Major and minor complications, speech and swallowing assessment, oral cavity obliteration, premaxillary contact, tongue elevation, and tongue protrusion.
There were no major complications, and 2 of the 13 patients experienced minor complications. Of the 13 patients, 12 achieved the goals of oral cavity obliteration and premaxillary contact and resumed solid oral intake. One patient remained G-tube dependent owing to toxic effects from previous chemoradiation treatment. The mean tongue tip protrusion was 0.7 cm (range, 0-1.7 cm), and the mean elevation was 1.7 cm (range, 1-3 cm). Patients with protrusion greater than 0.8 cm had better swallowing scores for "range of solids" (5.8 of 6 vs 3.9 of 6; P = .045) and "eating in public" (4.6 of 5 vs 3.5 of 5; P = .10). The average patient resumed a full range of liquid and solid intake with minimal restrictions and believed that their speech was mostly understandable with occasional repetition.
The template-based rectangle tongue flap effectively restored speech and swallowing function in this group of patients. Tongue protrusion greater than 0.8 cm is associated with better swallowing results.
Abstract
Background
The double-blind, randomized, phase 2 PALATINUS trial found a trend in prolongation of median overall survival (OS) with PAL+CET vs CET in CET-naive pts with platinum-resistant, ...HPV-unrelated HNSCC (median OS: 9.7 mo vs 7.8 mo, stratified by performance status PS hazard ratio HR=0.82, 95%CI: 0.54-1.25, P = 0.18). This subgroup analysis evaluated the efficacy and safety of PAL+CET in Asian pts enrolled in PALATINUS in Japan, Korea, and China.
Methods
Pts were treated with CET+PAL (arm A) or placebo (arm B) and stratified by PS and prior immunotherapy (IT). 120 pts were required for 1:1 randomization to have ≥80% power to detect an HR of 0.6 (corresponding to a median OS of 10 mo in arm A and 6 mo in arm B) using a 1-sided log-rank test at α = 0.10. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR; complete or partial response per RECIST v1.1), and adverse events (AEs).
Results
Of 125 pts randomized in PALATINUS, 28 were enrolled from Asian countries (arm A: 15; arm B: 13). PS and prior IT were balanced between groups. Unbalanced primary sites included hypopharynx (arm A: 9; arm B: 1) and oral cavity (arm A: 3; arm B: 7). Other pt characteristics were similar between the 2 arms. Median OS was 7.1 mo (95%CI: 3.1-8.8) in arm A and 7.0 mo (95%CI: 4.1-9.5) in arm B (stratified by PS: HR = 0.72, 95%CI: 0.3-1.8, P = 0.24). Median PFS was 3.2 mo in arm A and 3.0 mo in arm B (stratified by PS: HR = 1.22, 95%CI: 0.5-3.0, P = 0.3). ORR was 13.3% (95%CI: 1.7-40.5) in arm A and 15.4% (95%CI: 1.9-45.4) in arm B. Hematologic AEs were reported primarily in arm A. No difference in safety profile was shown in the Asian vs overall populations.
Conclusions
Although PAL+CET showed a trend toward prolongation of median OS vs CET in the overall PALATINUS population, no significant difference in OS or PFS was apparent with PAL+CET vs CET in the subgroup of Asian pts, possibly due to the limited cohort size.
Pfizer (NCT02499120)
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