No abstract

Background. Limb‐sparing surgery for soft tissue sarcomas of the extremities may result in microscopically positive surgical margins. The consequences of these microscopically positive margins are unknown. We have analyzed the influence of surgical margins on local disease control and overall survival in patients with extremity soft tissue sarcomas who received preoperative radiation therapy followed by limb‐sparing surgery. Methods. Ninety‐five consecutive patients with intermediate and high grade extremity sarcomas who received preoperative radiation therapy and limb‐sparing surgery were identified from a soft tissue sarcoma database. The clinical outcome of 24 patients who had microscopically positive surgical margins was compared with that of 71 patients who had clear surgical margins. Results. Multivariate statistical analysis revealed that patients with microscopically positive surgical margins or intraoperative tumor violation had an increased risk for local failure. High grade, large size, and intraoperative violation of the tumors were associated with decreased overall survival. However, neither the presence of a positive surgical margin nor the occurrence of a local failure adversely affected overall survival. Conclusions. Achieving negative surgical margins in patients with intermediate and high grade extremity sarcomas enhances local disease control but does not measurably improve overall survival. These data should be factored into patient management decisions in cases where the goal of achieving clear surgical margins requires amputation or the significant functional compromise of the extremity.

Esophagram is useful in the assessment of anatomic abnormalities but is a poor screening examination for the detection of esophageal dysmotility. Patients with suspected esophageal dysphagia should be referred for HRM to evaluate motility disorders and identify potential treatment targets, regardless of esophagram results.

5511 Background: EGFR expression is associated with poor prognosis and resistance of HNSCC to therapy. EGFR/Her2/neu heterodimers may potentiate receptor signaling and therapy resistance. T enhances cytotoxic effects of C and P in Her2/neu+ cell lines. Methods: A phase II trial evaluated the response rate (RR) of HNSCC pts to TPC as a function of Her2/neu and EGFR expression by immunohistochemistry (IHC). Secondary outcomes included toxicity, one-year progression-free (PFS) and overall (OS) survival. Eligible pts had M or R HNSCC, ECOG PS 0–1, CrCl >50 ml/min, and ANC >1500. Chemotherapy regimen consisted of P (175 mg/m2) and C (75 mg/m2) IV on day 1 and T (4 mg/kg day 1, cycle 1, 2 mg/kg subsequent) IV on day 1, 8 and 15 of 21. Paraffin embedded tumor was analyzed for Her2/neu (HercepTest) and EGFR (Zymed Lab) expression by IHC and for Her2/neu amplification by FISH (−/+) at LabCorp. Two-stage Simon design had 80% power for a 15% improvement in RR over 35% and required response in ≥ 14/42 pts by ECOG response criteria. Results: 61 pts (55 R HNSCC) received a median of 4 cycles (range 1–14) of TPC. Membrane staining of ≥ 10% of cells was observed for Her2/neu in 4/58 (6.9%, 95% CI 2–17) and for EGFR in 41/57 (72%, 95% CI 58–83). Her2/neu amplification was absent in 55/55 (0%, one-sided 97.5% CI 0–6.7) tumors. A RR of 36% (95% CI 24–50) was observed in 58 evaluable pts. RR was lower in pts with ≥ 10% staining by EGFR (25% versus 62.5%, p = 0.01). Her2/neu expression had no effect on RR (p = 0.75). Toxicities included two grade 5 dehydration/hypokalemia, and grade 3–4 neutropenia, fatigue, infection, nausea, vomiting, and neuropathy were common. Median follow-up was 4.2 yrs. For all 61 pts: median TTP was 4.3 mos, PFS 19.8% (95% CI 10.6–30.9) and OS 44% (95% CI 31.6–56.2) at 1 yr. Pts with <10% EGFR membrane staining had improved median PFS (6.7 vs 3.1 mos, p = 0.003) and OS (16.1 vs 7.4 mos, p = 0.005) when compared to patients with tumors with ≥ 10% EGFR. Conclusions: T did not improve RR to PC, likely because Her2/neu gene amplification and expression was rare. Tumor EGFR status significantly affected RR, PFS, and OS to the underlying regimen of PC. Sponsored by Bristol-Myers Squibb, Genentech, and Damon Runyon Cancer Research Foundation (MG). [Table: see text]

260 Background: Pre-chemotherapy teaching sessions, often coordinated by nursing personnel, are an opportunity to educate patients on treatment side effects, schedule, medications for toxicities such as nausea, and how to contact the oncology team if adverse events develop. Our institution provides a structured 60-minute nurse-coordinated pre-chemotherapy teaching session. The aims of this study were to evaluate whether pre-chemotherapy teaching sessions improve patient knowledge, preparedness, and anxiety in relation to chemotherapy. Methods: Patients were offered the opportunity to participate in the study after their medical oncologist had reviewed their treatment regimen. After informed consent was obtained, participants were administered a 10-question survey assessing knowledge of treatment adverse effects, treatment schedule, management of complications, accessing their medical team, and patient anxiety. Subjects then participated in a pre-chemotherapy teaching session with an oncology nurse. The survey was readministered when patients returned on day 1, cycle 1 of treatment and on day 1, cycle 2. The questionnaire used a 1 to 4 rating scale (1=no knowledge, 2= minimally informed, 3= reasonably informed, 4= well informed). A pre-defined mean change of 1 on the rating scale was considered to be clinically significant. Paired one-sided t-tests were performed to evaluate the mean change in groups between each of the three surveys. p values <0.05 were considered statistically significant. Results: At the time of analysis, 78 patients had completed a pre-chemotherapy teaching session and all three surveys. After participating in a teaching session, there was an increase in patient’s perceived knowledge of side effects (mean score 2.3 vs. 3.5, p<0.001), knowledge of the treatment schedule (mean score 2.4 vs. 3.5, p<0.001) and medications to prevent nausea (mean score of 1.4 vs. 3.1, p <0.001). There was also a statistically significant reduction in patient anxiety in relation to treatment, p< 0.001. Conclusions: These results show that a nurse-coordinated, pre-chemotherapy teaching session increases patient knowledge and reduces anxiety regarding their upcoming treatment.