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Palbociclib (PAL) 1 cetuximab (CET) vs CET in patients (PTS) with head and neck cancer: Asian subgroup analysis [Meeting Abstract]

Tahara, M; Ching, Lin J; Sacco, A; Ley, J; Oppelt, P; Shen, Q; Kern, K; Thurm, H; Wang, S L; Martini, J F; Hoffman, J; Melichar, B; Adkins, D
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 7.8mo, 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.
Method(s): 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 6mo in arm B) using a 1-sided log-rank test at alpha=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).
Result(s): 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 7.0mo (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.
Conclusion(s): 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
EMBASE:630553753
ISSN: 1569-8041
CID: 4266592

Long-term response to fractionated radiotherapy of presumed optic nerve sheath meningioma

Lesser, Robert L; Knisely, Jonathan P S; Wang, Silas L; Yu, James B; Kupersmith, Mark J
BACKGROUND/AIMS To review the long-term results of treatment of optic nerve sheath meningiomas (ONSMs) with conformal radiotherapy. METHODS Eleven patients with presumed ONSM were treated with fractionated conformal radiotherapy using 45-54 Gy in 25-30 fractions and followed for more than 5 years. Affected eye visual acuity in logMAR notation, colour vision, threshold perimetry, mean deviation (dB) and imaging were studied before and after treatment. ANALYSIS Included adverse effects of treatment and the frequency of affected eye maintained or improved vision. RESULTS There were nine women and two men with a mean age of 45.3. Vision or field loss was the most common presentation. All had abnormal MR imaging. The follow-up period after radiotherapy was 61-156 months (mean 89.6). Visual acuity was unchanged or improved in 10 patients (91%). The average difference between pretreatment and final logMAR visual acuity was 0.08, while the average difference in visual-field mean deviation was -4.63 dB. The radiographic appearance of the tumours was stable in size in nine patients and decreased in two. No major side effects from radiation were seen. CONCLUSIONS Vision, MRI and complication outcomes are favourable for using fractionated conformal radiotherapy for ONSM.
PMID: 19965820
ISSN: 0007-1161
CID: 159156

Design principles for developing an efficient clinical anatomy course

Rizzolo, Lawrence J; Stewart, William B; O'Brien, Michael; Haims, Andrew; Rando, William; Abrahams, James; Dunne, Shane; Wang, Silas; Aden, Marcus
The exponential growth of medical knowledge presents a challenge for the medical school curriculum. Because anatomy is traditionally a long course, it is an attractive target to reduce course hours, yet designing courses that produce students with less understanding of human anatomy is not a viable option. Faced with the challenge of teaching more anatomy with less time, we set out to understand how students employ instructional media to learn anatomy inside and outside of the classroom. We developed a series of pilot programs to explore how students learn anatomy and, in particular, how they combine instructional technology with more traditional classroom and laboratory-based learning. We then integrated what we learned with principles of effective instruction to design a course that makes the most efficient use of students' in-class and out-of-class learning. Overall, we concluded that our new anatomy course needed to focus on transforming how medical students think, reason, and learn. We are currently testing the hypothesis that this novel approach will enhance the ability of students to recall and expand their base of anatomical knowledge throughout their medical school training and beyond.
PMID: 16707295
ISSN: 0142-159x
CID: 159157