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e18552 Background: The classification of thymic epithelial neoplasms is subject of controversy. The purpose of our investigation is to see whether the 2004 histologic classification results in better prognostic categories than that of the 1999 classification. Methods: The SEER 18 database was used to investigate incidence and overall survival/cause-specific survival (OS/CSS) of resected thymomas during 2000-2009. Incidence was examined by frequency and trend analyses. Patients diagnosed with first primary localized thymoma/thymic carcinoma were selected in two time periods (2000-2003: N=201; 2005-2009: N = 497). The median follow up is 79 months and 27 months respectively. OS/CSS in two patients group were analyzed by Kaplan-Meier estimation, log-rank tests, and multivariate proportional hazards modeling. Results: The proportion of six histology categories (A, AB, B1-B3,C) did not change significantly during the two time periods. Compared to patients diagnosed in 2000-2003, OS was not significantly different in patients diagnosed in 2005-2009 in the log rank tests or multivariate analysis after accounting for treatment, tumor factors, and patient characteristics (OS, HR=0.737, p=0.1580; CSS, HR=0.731, p=0.3711). Histology as 6 categories is a significant predictor for OS in the multivariate analysis in 2005-2009, but not in 2000-2003. However, the predictive role of histology is similar in both time periods in the multivariate analysis of CSS. Complete resection, classification C, and tumor stage are significantly linked to OS and CSS. Conclusions: Patients diagnosed after 2004 did not have better survival outcomes than earlier patients. The WHO classification of 2004 may be a better predictor of OS than that of 1999 as shown by the wide-spectrum of pathologists reporting to SEER.

7554 Background: Lymphatic-vascular invasion (LVI) is not currently considered in staging of non-small cell lung cancer (NSCLC). We assessed the impact of LVI on overall survival (OS), local/distant recurrence (LR/DR) and patterns of recurrence. Methods: 869 consecutive patients who underwent a definitive surgical resection ± adjuvant chemotherapy for NSCLC from 2000–2008 were qualified for analysis if they did not receive any adjuvant/neo-adjuvant radiotherapy, had at least three months of follow-up, and did not have a history of other cancers within 5 years. Tumors with LVI (N = 160) were compared to tumors without LVI (N = 705). LR/DR rates at 2,3, and 5 years were calculated by the methods of Kaplan-Meier. Association between LVI and OS and LR/DR were compared in the total population and in a propensity matched population (PS) by factors affecting OS and LR/DR (n=160 matched pairs). Results: OS, LR, and DR were significantly worse in patients with LVI in the total population and in the subset of patients matched by propensity score (Table). In the PS-matched pairs, LVI was associated with a greater number of N1 nodes involved, a longer length of stay, higher histologic grade, and higher T-stage. Patterns of local failure (P

e18506 Background: As compared to wedge resection (WR), anatomic segmentectomy (AS) may result in a more thorough resection because it allows bronchial and vascular dissection in a manner similar to a lobectomy and greater access for lymphadedectomy. The purpose of our study is to assess if AS allows for lower loco-regional (LR)/distant (DR) recurrences, improved overall survival (OS), and greater ability to resect lymph nodes as compared to WR. Methods: A multi-institutional database of consecutive patients undergoing surgical resection with negative margins for Stage I NSCLC FROM 1998-2009 was used. 2,300 patients had stage I NSCLC(

G A A b st ra ct s chose acid, 8 sweet, 3 bitter. Subjective improvement in swallowing was reported by 10 patients, 6/8 on sweet thickener, 2/9 on acid, and 2/3 on bitter thickener. Objective improvement of the SDQ score was reported by 13/20, patients 5/9 on acid thickener, 7/8 on sweet, and 1/3 on bitter. Score for cough during swallowing of liquid was rated 2.2±1.0 on usual diet and 1.8±1.0 (p,0.03) after 6 weeks on preferred taste thickener. There was not significant body weight variation during the study period: 20% increased .1 Kg, 65% remained stable ,and 15 decreased .1 kg. Conclusions. Taste can affect swallowing function in ALS patients, being sweet and acid the most preferred and effective flavors. Flavoring liquid thickener with individualized selected taste can improve the swallowing act in ALS patients. 1) Logemann JA et al. J Speech Hear Res 1995;38:556-63 2) Cohen JT, Manor Y. The laryngoscope 2011

OBJECTIVE: The authors determined whether some patients with clinical stage I or II invasive breast cancer can be adequately treated by conservative surgery without radiotherapy. SUMMARY BACKGROUND DATA: Currently, there are many patients who are being treated in this manner in both academic and community hospitals. This approach is not as effective as either mastectomy or conservative surgery followed by radiotherapy in preventing local recurrence. However, there may be subsets of patients who might be adequately treated by surgery alone with acceptably low recurrence rates. METHODS: The authors reviewed retrospective studies of conservative surgery alone and of randomized trials comparing the results of treatment with and without postoperative radiotherapy. RESULTS: The local recurrence rate is unacceptably high when random patients are treated with conservative surgery without radiotherapy. More favorable results may be possible when relatively wide excisions are performed on selected postmenopausal patients with small lesions without an extensive intraductal component, lymphatic or blood-vessel invasion, and histologically negative axillary nodes. The role of tamoxifen in reducing the risk of breast recurrence is uncertain. Despite salvage therapy, some individuals may develop disseminated disease as a result of local recurrence. CONCLUSIONS: The authors believe that conducting carefully designed prospective studies of conservative surgery alone is reasonable for patients who are adequately informed of the potential risks of omitting radiation therapy. However, currently, patients should not be treated with conservative surgery alone (without radiotherapy) without such stringent guidelines.

6022 Background: Results from ACOSOG Z0011 suggest axillary lymph node dissection (ALND) may not be necessary for patients following positive sentinel lymph node biopsy (SLNB). Concerns have been raised regarding generalizability of this trial, given the low-risk patient population. It is uncertain whether a subgroup who would have been eligible for ACOSOG Z0011 but were not adequately represented in the study may still benefit from ALND. Methods: We constructed a decision analysis using a Monte Carlo model to simulate axillary recurrence risk, lymphedema, and quality of life of women aged 45, 55 and 75 y/o with Stage II cancers following breast conserving surgery (BCS) with positive SLNB who were then treated with ALND and whole-breast radiation (BRT) or BRT alone. Women were divided into two risk groups based on the Memorial Sloan-Kettering Cancer Center non-sentinel lymph node (NSLN) nomogram: those with risk of residual nodal involvement of 30-60% (high risk); and those with risk less than 30% (low risk, similar to the Z0011 patients). Probabilities and utilities for health states were derived from prior studies. Results: BRT alone resulted in improved quality-adjusted life expectancy (QALE) in the low-risk group, while ALND with BRT resulted in improved QALE in the high-risk group. Overall survival (OS) was similar at 5 years with both treatment strategies in both groups but was superior with ALND at 20 years in the high risk group (Table). Differences in outcomes decreased with increasing age. In the low-risk group, sensitivity analysis showed BRT alone is preferred unless the axillary recurrence risk with BRT is greater than 1.6% or the lymphedema risk with ALND is less than 10%. In the high-risk group, ALND with BRT is the preferred strategy unless the axillary recurrence risk with BRT is less than 2.3%. Conclusions: Patients who would have been eligible for ACOSOG Z0011 but are at higher risk of having residual nodal disease following BCS and positive SLNB may benefit from ALND plus BRT rather than BRT alone. [Table: see text]

7055 Background: The Lung Cancer Screening Trial has shown an overall survival (OS) benefit and reduced lung cancer mortality in the 55-74 age group (gp). We chose to evaluate whether NSCLC patients aged 75-84 are increasing in the USA and whether they would benefit from aggressive therapy. Methods: SEER-17 was used to calculate NSCLC rates during the years 2000-2008. SEER-9 was used to estimate the proportional change in both 55-74 and 75-84 gp from 1973-2008. OS was analyzed in a modern population from SEER-17 (2004-2008) to assess the effects of increasingly aggressive therapy (observation(Ob), radiation (RT) or lobectomy (LB)) for a proposed screening population with T1N0 tumors. Chi-square test and Cox Regression (CR) were used to evaluate OS. Paired T-tests assessed changes in rates and proportions over time. Results: The 55-74 gp rose from 64.4% in 1973 to 67.25% in 1984, but fell to 58.8% by 2008, while the 75-84 gp rose from 12.1% in 1973 to 24% in 2008 (p

7040 Background: Stereotactic body radiotherapy (SBRT) is an alternative to surgery alone for certain patients with clinical stage I non-small cell lung cancer (NSCLC), but comparing their effectiveness is difficult because of differences in patient selection and staging. Methods: Two databases were combined which contained 132 patients treated by lobectomy (LR) and 48 by sublobar resection (SLR) and 137 patients managed with SBRT after negative staging between 1999-2009. We compared rates of overall survival (OS), disease-free survival (DFS), and locoregional control (LRC) between patients treated with surgery and SBRT to each other and in relation to possible prognostic factors. We then performed a matched-pair analysis comparing surgery and SBRT results. Median follow-up for the entire study population was 25.8 months. Results: On univariate analysis, OS was significantly correlated with histology, the Charlson Comorbidity Index, tumor size, aspirin use, and use of SBRT; DFS was correlated only with histology; and no variable was significantly correlated with LRC. Multivariate analysis found improved OS in patients with adenocarcinoma and those undergoing surgical resection. The NSCLC “not otherwise specified” histology was associated with poorer DFS. Overall survival was significantly poorer for SBRT patients in the matched-pair analysis than for patients treated with surgery, but DFS and LRC were not significantly different between these groups. Conclusions: Our retrospective study has demonstrated similar LRC and DFS in patients treated with SBRT or surgery, but worse OS in the former group, when patients were matched for prognostic factors. Our investigation suggests that randomized trials are needed to eliminate selection bias in treatment assignment in order to accurately compare outcomes between these approaches.

7054 Background: SG, both adenoid cystic (ACC) and mucoepidermoid (ME) sub-types, are rare lung cancers. We choose to investigate the incidence of these rare sub-types and assess their difference in presentation and prognostic characteristics in comparison to adenocarcinomas (Ad) and squamous cell carcinomas (SCC) during the same time period. Methods: The SEER-17 database was used to collect data during the years 1988-2008. Differences between populations were determined by the chi-square test. Survival curves were generated as Kaplan-Meier techniques. Cox proportional hazards test was used to compare survival differences. Results: During the 20-year study period, ACC (n =100) and ME (n= 178) accounted for 0.03% and 0.06% of NSCLCs. Mean follow-up was 34.5 months for all patients. In comparison to ACC, patients with ME were significantly more likely to be younger (52 yr vs. 60yr), Asian(11.7% vs. 7%), have Stage I disease (62.9% vs 24.0%), and less likely to be in the mainstem bronchi (17.2% vs. 6.3%). In comparison to patients with patients presenting with either SCC or Ad, both ME and ACC were significantly less likely to present with Stage IV disease (26.6% SCC, 41.29% Ad, 16.73% SG), have nodal involvement (35.1% SCC, 27.4% Ad, 23.37% SG), and be older (70 SCC, 68 Ad, 58 years SG). Stratified by stage and treatment, there was no survival (OS) or disease-specific survival difference (DSS) between ACC and ME. The OS of the combined group of ME and ACC was significantly better stage per stage than either Ad (Hazard ratio (HR) range = 0.26- 041), and SCC (HR range = 0.17-0.56). Lung Cancer-Specific survival at 2,3,5 years for surgically-resected Stage I ACC and ME were 83.5%, 80.4%, and 80.4%; and 82.6%, 78.0% and 78%, respectively. Conclusions: Patients with ACC and ME have rare sub-types of lung cancer that present differently and have better survival than patients presenting with either of the more common histologic sub-types (SCC and Ad) of NSCLC. We encourage prospective, multi-institutional studies of these rare sub-types so that care can be optimized. Optimal care may differ for SG because of their stage per stage better prognosis than other NSCLCs.

Purpose: The purpose of the present study is to evaluate the outcome of salvage treatment for local recurrence in the breast following the initial treatment of ductal carcinoma in situ (intraductal carcinoma) with breast-conserving surgery and definitive breast irradiation. Methods and Materials: An analysis was performed of 42 local failures in the breast that occurred following the initial treatment of ductal carcinoma in situ (intraductal carcinoma) with breast-conserving surgery and definitive breast irradiation. At the time of the local recurrence, 23 cases (55%) showed invasive ductal carcinoma, and 19 cases (45%) showed intraductal carcinoma, one with associated Paget's disease. The surgical treatment at the time of local recurrence included mastectomy ( n = 39), excision ( n = 2), or other ( n = 1). Adjuvant systemic therapy at the time of local recurrence included chemotherapy ( n = 2), hormonal treatment ( n = 7), both ( n = 1), or none ( n = 32). The median follow-up after salvage treatment was 3.7 years (mean = 4.0 years; range=0.1–9.5 years). Results: The 5-year actuarial outcome following salvage treatment for the 42 local recurrences showed an overall survival rate of 78%) and a cause-specific survival rate of 84%. The 5-year actuarial rate of freedom from distant metastases was 86%. None of the patients with histology of the local recurrence of intraductal carcinoma or with detection of the local recurrence with mammographic findings only developed distant metastatic disease after salvage treatment. The 5-year actuarial rate of freedom from chest wall recurrence following salvage mastectomy was 92%. All three of the patients who developed chest wall recurrence following salvage mastectomy also developed distant metastatic disease. Conclusions: These results demonstrate that local recurrences following the initial treatment of ductal carcinoma in situ with breast-conserving surgery and definitive breast irradiation can be salvaged with high rates of survival, freedom from distant metastases, and freedom from chest wall recurrence. The results of salvage treatment support the use of breast-conserving surgery and definitive breast irradiation for the initial management of ductal carcinoma in situ of the breast.

Purpose: This analysis was performed to clarify the relationship between the surgery-radiotherapy interval and the risk of recurrence in patients treated with breast-conserving therapy for early stage invasive cancers. Methods and Materials: We retrospectively analyzed data from 653 patients with American Joint Commission on Cancer Stage I or 1I, pathologically node-negative breast cancer treated by breast-conserving therapy without adjuvant systemic therapy between 1968 and 1985. All patients received a dose of at least 60 Gy to the tumor bed. Two hundred and eighty-three patients started radiotherapy within 4 weeks of surgery, 308 started 5–8 weeks after surgery, and 54 started 9–12 weeks after surgery. Median follow-up in the 531 survivors was 100 months. Results: Pathologic features and treatment characteristics were well balanced between the groups with surgery-radiotherapy intervals of 0–4 weeks and 5–8 weeks. There was no statistically significant difference in the risk of overall recurrence among patients starting radiotherapy 5–8 weeks after surgery compared with those treated within 4 weeks. Analysis of the 5-year crude rates of failure further demonstrated no difference in the distribution of sites of failure in the 5–8 week group compared with the 0–4 week group. A multivariate model controlling for known risk factors, as well as potential treatment-related confounders, also failed to demonstrate an increased risk of recurrence with the longer surgery-radiotherapy interval (risk ratio=0.89, p = 0.44). Conclusion: This retrospective analysis suggests that a delay of up to 8 weeks in the interval between the last breast surgery and the start of radiotherapy is not associated with an increased risk of recurrence in patients with early stage breast cancer treated with breast irradiation to at least 60 Gy without systemic therapy.

Purpose: To investigate whether etanidazole and cisplatin can be given safely together and to evaluate the relationship between incidence of peripheral neuropathy and cumulative exposure to etanidazole and cisplatin, as well as other toxicities and treatment outcome. Methods and Materials: Thirty-two previously untreated patients with locally advanced esophageal cancer were entered on a Phase I study of etanidazole combined with radiation therapy and chemotherapy. Cisplatin/5-FU (two cycles, weeks 1 and 4) and etanidazole (weeks 2, 3 and 5) were given concurrently with radiation therapy. Eligible patients then underwent surgical resection. All patients were scheduled to receive two additional cycles of cisplatin/ 5-FU chemotherapy after completion of radiation therapy (definitive arm) or surgery (preoperative arm). Results: Of 19 fully evaluable patients, nine (47%) developed peripheral neuropathy. Six of six patients, 65 years or older, experienced peripheral neuropathy, compared with three of 13 patients less than 65 years old ( p = .003). For patients younger than 65 years, two of the two patients with single dose area under the curve (AUC) > 4.0 mMhr experienced peripheral neuropathy, compared with one of 11 patients with single-dose AUC p = .03). Grade 4 toxicity included neutropenia (23%) and thrombocytopenia (26%). No other Grade 4 toxicity was observed. The pathologic complete response rate in patients who underwent surgical resection was 29%. Conclusion: This regime of chemotherapy, radiotherapy, and etanidazole had acceptable toxicity. However, combining etanidazole and cisplatin appears to increase the risk of developing peripheral neuropathy for at least some categories of patients. Further studies of these interactions are needed.

PURPOSE This analysis was performed to clarify the relationship of young age at diagnosis to the pathologic features of the tumor and prognosis in patients with early-stage breast cancer. PATIENTS AND METHODS We retrospectively analyzed data from 1,398 patients with American Joint Committee on Cancer Staging stage I or II breast cancer treated by breast-conserving therapy between 1968 and 1985. One hundred seven patients were younger than 35 years at the time of diagnosis. The median follow-up duration for the 1,032 survivors was 99 months. RESULTS Patients younger than 35 years had a significantly higher overall recurrence rate (P = .002), as well as a greater risk for developing distant metastases (P = .03), when compared with older patients. The cancers in younger patients more commonly showed factors associated with a worse prognosis (including grade 3 histology, lymphatic vessel invasion [LVI], necrosis, and estrogen receptor [ER] negativity) as compared with older patients. In a proportional hazards model that included clinical and treatment-related variables, as well as these pathologic features, age younger than 35 years remained a significant predictor for time to recurrence (relative risk [RR], 1.70), time to distant failure (RR, 1.60), and overall mortality (RR, 1.50). CONCLUSION Breast cancer patients younger than 35 years have a worse prognosis than older patients. This difference is only partially explained by a higher frequency of adverse pathologic factors seen in younger patients.

7542 Background: To assess surgical, histopathologic, and patient-related factors associated with isolated brain metastases (IBM) in patients with stages I-IIIA non-small cell carcinoma (NSCLC) who underwent a definitive surgical resection ± adjuvant chemotherapy as compared to patients developing other distal metastases (ODM). Methods: 593 consecutive patients who underwent a definitive surgical resection ± adjuvant chemotherapy for NSCLC from 2000–2007 were qualified for analysis if they did not receive any adjuvant/neo-adjuvant radiotherapy, had at least three months of follow-up, and did not have a history of other cancers within 5 years of the diagnosis of their NSCLC. Univariate and multi-variate analyses were performed to assess risk factors for IBM as the only site of metastatic relapse and compare these risk factors to those of patients with ODM. Results: After a median follow-up of 33 months, 92 patients (25 IBM and 67 ODM) presented with distal metastases. Median time to the development of IBM ...

The management of patients with ductal carcinoma in situ (DCIS) is among the most controversial topics in the field of breast cancer. In the past, DCIS was an uncommon lesion that usually presented as a palpable mass. With the advent of Screening mammography the incidence of DCIS has increased markedly. The success of breast-conserving treatment for invasive carcinomas (National Institutes of Health 1991) has also led to increased interest in avoiding mastectomy in patients with noninvasive cancers. However, the traditional therapy of DCIS has been mastectomy.

PURPOSE The prognosis and factors that influence prognosis following salvage mastectomy in patients with recurrence in the treated breast after conservative surgery (CS) and radiation therapy (RT) were investigated. MATERIALS AND METHODS A total of 1,593 patients with stage I or II invasive breast cancer were treated following gross total excision of the tumor at the Joint Center for Radiation Therapy (JCRT) between 1968 and 1985. One hundred sixty-six of the 1,593 (10%) had subsequent recurrence in the breast. Of these, 123 had salvage mastectomy and constitute the study population. The recurrent tumor was predominantly invasive in 99 patients, noninvasive in 14, and focally invasive in 10. Following mastectomy, chemotherapy or hormonal therapy was administered to 29 patients. The median follow-up time was 39 months after salvage mastectomy. RESULTS The 5-year actuarial rate of further local or distant relapse for the entire group was 41%. None of the 24 patients with focally invasive or noninvasive tumors had a subsequent relapse. In comparison, the 5-year actuarial rate of further relapse in the 99 patients with a predominantly invasive recurrence was 52% (P = .001). The method of detection of the recurrence, the age of the patient at initial diagnosis, the disease-free interval, and the location of the recurrence in the breast were not found to have a statistically significant association with the risk of further relapse. CONCLUSION We conclude that the histology of the recurrent tumor is an important prognostic factor for the risk of further relapse. Patients with purely noninvasive or focally invasive tumors have an excellent prognosis following salvage mastectomy. In contrast, patients with predominantly invasive tumors are at substantial risk for further relapse.

The use of breast-conserving treatment (combining breast-conserving surgery and irradiation, RT) had been well established based on the results of clinical trials demonstrating equivalent survival for patients with early-stage breast cancer treated by this approach or by mastectomy [1–5]. Breast- conserving treatment results in important gains in body image and sexuality for many patients and is now widely used in both the United States and Europe. Over a similar time frame, clinical trials have also demonstrated the effectiveness of adjuvant systemic therapies in prolonging survival [6] (reprinted in part in this volume). Therefore clinicians are now commonly faced with the necessity of combining RT and systemic therapy in patients following conservative surgery. In this chapter we review the available information regarding the integration of RT and chemotherapy (CT) following conservative surgery. We do not address issues related to the combination of RT and tamoxifen or the use of initial CT (discussed elsewhere in this volume).

7069 Background: We recently demonstrated that DM was an independent risk factor for LR for patients undergoing resection of NSCLC. This investigation was performed to confirm or refute this findin...

Until recently, the critical issue regarding breast-conserving therapy for patients with early-stage invasive breast cancer was whether it could yield survival equal to mastectomy. This has now been demonstrated in several randomized prospective trials [1, 2, 3, 4, 5]. As discussed in earlier chapters, the value of adjuvant systemic therapy in the management of at least some subsets of these patients has now been widely accepted. These two developments have resulted in many patients being treated with both breast-conserving therapy and adjuvant systemic therapy.

To assess the cosmetic results in relation to treatment technique, we retrospectively reviewed the results for 1159 Stage I-II breast cancer patients treated with conservative surgery and radiotherapy between 1970-1985. All patients underwent gross excision followed by radiation therapy including an implant or electron beam boost. The total dose to the primary site was greater than or equal to 60 Gy. Because of technical modifications introduced over time after 1981, the population was divided arbitrarily into two cohorts: 504 patients treated through 1981 and 655 treated between 1982-1985. Median follow-up time for surviving patients in the two cohorts were 107 months and 67 months, respectively. Cosmetic outcome was evaluated by the examining physician and scored as excellent, good, fair or poor. Excellent results at 5 years were scored in 59% of early cohort patients and 74% of the latter cohort (p = 0.002). Acceptable results (either good or excellent) were seen in 84% and 94%, respectively (p = 0.02). In the latter cohort, the likelihood of achieving an excellent result, but not an acceptable result, was significantly related to the volume of resected breast tissue and the use of chemotherapy. The number of fields (three-field technique, provided that fields are precisely matched, compared to tangents only) and boost type (implant vs electrons) did not influence the cosmetic outcome. We conclude that our current technique using breast RT to 45-46 Gy and a boost to the primary site of 16-18 Gy is associated with a high likelihood of acceptable cosmetic results and that this likelihood is not diminished by the use of adjuvant chemotherapy, a large breast resection, the use of a third field, or boost type.

The frequency of brachial plexopathy, rib fracture, tissue necrosis, pericarditis, and second non-breast malignancies occurring in the treatment field among 1624 patients with early stage breast cancer treated with conservative surgery and radiation therapy at the Joint Center for Radiation Therapy between 1968 and 1985 is reported. The median follow-up time for survivors was 79 months (range 5-233 months). Brachial plexopathy was related to the use of a third field, the use of chemotherapy and the total dose to the axilla. Brachial plexopathy developed in 20 of 1117 women (1.8%) who received supraclavicular irradiation with or without axillary irradiation. The median time to its occurrence was 10.5 months (range 1.5-77 mo), and the majority (80%) of cases completely resolved. Among patients treated with a three-field technique, the incidence of brachial plexopathy was 1.3% (13/991) in patients treated with a dose to the axilla of less than or equal to 50 Gy, compared with 5.6% (7/126) in women treated with an axillary dose of greater than 50 Gy. The incidence of brachial plexopathy was 4.5% (15/330) among patients receiving chemotherapy, compared with 0.6% (5/787) when chemotherapy was not used (p less than 0.0001). Rib fracture was seen in 29 patients (1.8%), at a median time of 12 months following treatment (range 1-57). In all cases, the rib fracture healed without intervention. The incidence of rib fracture was 2.2% (28/1300) among patients treated on a 4 MV linear accelerator, compared with 0.4% (1/276) for patients treated on a 6 or 8 MV machine (p = 0.05). Of patients treated on a 4 MV machine, 0.4% (1/279) developed a rib fracture when a whole breast dose of 45 Gy or less was given, 1.4% (10/725) after receiving between 45 and 50 Gy, and 5.7% (17/296) following 50 Gy or higher. Tissue necrosis requiring surgical correction developed in three patients (0.18%) 22, 25, and 114 months after treatment. Presumed pericarditis (requiring hospitalization) was seen in 0.4% of women (3/831) who received radiation therapy to the left breast 2, 2, and 11 months after the start of treatment. Three women (0.18%) developed sarcomas in the treatments field at 72, 107, and 110 months, for a 10-year actuarial rate of 0.8%. Two of these sarcomas developed in areas of probable match-line overlap. One patient (0.06%) developed an in-field basal cell carcinoma at 42 months. In conclusion, the risk of significant complications following conservative surgery and radiation therapy for early stage breast cancer is low.(ABSTRACT TRUNCATED AT 400 WORDS)

Introduction: The indications for postmastectomy radiation therapy (PMRT) have expanded over the past decade. Plastic surgeons are reluctant to perform an immediate reconstruction followed by radiation because of their perception this sequence results in worse results. This study examines the relationship between the use and sequencing of radiation therapy on complication rates and patient satisfaction following reconstrucion.Methods: A retrospective chart review was performed of all women at an academic institution who underwent mastectomy and reconstruction from 1999-2006. The 769 reconstructed breasts were separated into 4 groups: PMRT prior to delayed reconstruction (n = 60); immediate reconstruction then PMRT (n = 56); reconstruction without PMRT (n = 540); and reconstruction after breast-conserving therapy with RT (BCT-RT, n = 113). The median length of follow-up was 44 months. All operative complications were categorized into early (≤90 days) or late. A questionnaire based on the Michigan Breast Reconstruction Outcomes Study assessed general and aesthetic satisfaction (response rate, 73.2%). Dichotomous variables were evaluated using the Fisher's exact or chi-squared test; statistical significance was set at p Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 4102.

Purpose/Objective(s): The Lung Cancer Study Group’s Trial of lobectomy (L+) vs. limited resection (L-) for Stage I NSCLC revealed a higher rate of local recurrence (LR) (defined as ipsilateral lung and mediastinum) in the Lgroup. The purpose of this investigation is to identify a patient subgroup undergoing Lwho would be at an increased risk of local recurrence and to assess failure patterns between the two types of resection.

7585 Background: Small cell lung cancer (SCLC) rarely presents as I/II Disease. In order to assess the incidence, treatment and prognosis of this early-stage SCLC, we used the Surveillance, Epidemiology and End Results database. Furthermore, since some investigators are irradiating growing and/or PET Scan positive nodules without biopsy, presenting characteristics of surgically-resected Stage I SCLC were compared to those of non-small cell lung cancer (NSCLC). Methods: The SEER 17 Database from 1988–2003 was accessed for all patients with early-stage SCLC. Presenting characteristics of surgically-resected Stage I SCLC were compared to those of resected Stage I NSCLC using chi-square and Wilcoxon Rank Sum tests. The logrank test was used to compare the differences in Survival(S) resulting from the various treatments options for early-stage SCLC. Results: 1,615 patients were identified with early-stage SCLC with greater than 3 months of follow-up. The median S was 20 months for the entire group. Over the time period of our study, the incidence of early stage SCLC as a percentage of all SCLCs and all lung cancers (SCLCs and NSCLCs) remained stable and ranged from 3.00–4.96% and 0.09–0.16% respectively. Surgically-resected Stage I SCLC did not differ from NSCLC in regards to patient characteristics (age, sex, race) or tumor location, but SCLC was found to have significantly smaller tumor size (p< 0.0001). Lobectomy or greater resections without radiotherapy were associated with a greater median S than those treated with segmental/wedge resections and those treated with radiotherapy alone (44 vs 29 months, p=0.03 and 20 months, p No significant financial relationships to disclose.

7583 Background: To examine the effects of different definitions of local recurrence on the reported patterns of failure and associated risk factors in patients undergoing potentially curative resection of Stage I non-small cell lung cancer (NSCLC). Methods: The study included 306 consecutive patients treated from 2000–2005 without radiotherapy. Local recurrence was defined as either: “radiation” (i.e., recurrences confined to the post-operative radiotherapy fields used in the Phase III trial of adjuvant radiotherapy by Trodella et al) (LRR), including the bronchial stump, staple line, the ipsilateral hilum, and ipsilateral mediastinum; or “comprehensive” (LRC), including these sites plus the ipsilateral lung and contralateral mediastinal and hilar nodes. Results: The median follow-up was 33 months. Proportions of LRC and LRR at 2, 3 and 5 years were 14%, 21% and 29%; and 7%, 12%, and 16%, respectively. Significant risk factors for LRC on multivariable analysis were diabetes, lymphatic vascular invasion and tumor size; significant factors for LRR were resection of less than a lobe and lymphatic vascular invasion. Distant (non-local) relapse proportions using these definitions at 2, 3 and 5 years were 10%, 12%, and 18%; and 14%, 19%, and 29%, respectively. Significant risk factors for distant failure were histology when using the LRC definitions and tumor size using the LRR definition. Conclusions: Local recurrence increased nearly two-fold when a broad definition was used, rather than a narrow one. The definition also affected which factors were significantly associated with both local and distant failure on multivariate analysis. Comparable definitions must be used when analyzing different series. No significant financial relationships to disclose.

The optimal extent of breast resection before irradiation for treatment of early breast cancer has not been defined. Increasing the size of the resection may decrease the risk of local recurrence but will also have an adverse impact on the cosmetic outcome. The 5-year likelihood of a recurrence of the tumor was analyzed in relation to the volume of resected breast tissue in 507 patients with infiltrating ductal carcinoma treated with conservative surgery and radiation therapy between 1968 and 1982. Patients were stratified by clinical T-stage and for each T-stage patients were divided into three groups of equal numbers based on the volume of excised tissue. All patients had at least a gross excision of the tumor and the extent of breast resection was determined at the discretion of the surgeon without knowledge of the histologic features of the tumor. The median follow-up time was 100 months. The 5-year actuarial recurrence rates were analyzed in relation to clinical T-stage (T1 or T2) and the presence or absence of an extensive intraductal component (EIC+ or EIC-). For patients with EIC+ tumors, the largest resections were associated with a substantially lower risk of recurrence in the breast than the smallest resections. This effect was seen both for T1 tumors (10% versus 29%, p = 0.07) and for T2 tumors (9% versus 36%, p = 0.04). For patients with EIC-tumors, recurrence rates were significantly lower than for EIC+ tumors and were not influenced by the volume of resection to the same degree as EIC+ tumors. In the absence of an EIC, recurrence rates for the largest and smallest resections were 0% and 9% (p = 0.02) for T1 tumors and 3% and 6% (p = NS) for T2 tumors. It is concluded that a limited breast resection is acceptable for an EIC- tumor but that a more extensive resection is required for an EIC+ tumor. These results stress the importance of assessing the presence or absence of an EIC in determining the optimal extent of breast resection required before radiation therapy.

The optimal means of combining breast-conserving surgery, radiation therapy, and chemotherapy for the treatment of patients with early-stage, node-positive breast cancer is not known. We reviewed the results in 295 patients treated at the Joint Center for Radiation Therapy and affiliated institutions from 1976 to 1985. All patients had positive axillary nodes on dissection, had no gross residual disease in the breast or axilla after surgery, and received breast irradiation (with or without nodal irradiation) and three or more cycles of a cyclophosphamide, methotrexate, and fluorouracil (CMF)-based or doxorubicin-containing regimen. Median follow-up in patients without any failure was 78 months. Breast failure rates were assessed in relation to the sequencing of radiotherapy and chemotherapy. The different sequences were not randomly assigned, and the characteristics of the sequence groups differed. The actuarial 5-year breast failure rate was 4% in 99 patients receiving radiotherapy before chemotherapy; 8% in 54 patients sequentially receiving some chemotherapy, then radiotherapy without concurrent chemotherapy, then further chemotherapy; and 6% in 116 patients receiving concurrent chemotherapy and radiotherapy. However, the failure rate was 41% in 26 patients who received all chemotherapy before radiotherapy. The crude incidences of local failure within 4 years of treatment in these groups were 3%, 2%, 4%, and 15%, respectively (P = .065 for all four groups not being the same). The actuarial 5-year local failure rate was 5% for 252 patients irradiated within 16 weeks after surgery compared with 35% for 34 patients irradiated more than 16 weeks after surgery. The 4-year crude incidences were 4% and 12% for the two groups, respectively (P = .06). These results suggest that delaying the initiation of radiotherapy may result in an increased likelihood of local failure. Formal randomized controlled trials will be needed to confirm these results and to improve the integration of these treatment modalities.

Adjuvant chemotherapy (CT) is increasingly being used in conjunction with radiation therapy (RT) in the treatment of early stage breast cancer. To assess the effect of CT on the cosmetic outcome of the irradiated breast, we retrospectively reviewed the cosmetic results of patients who received either cyclophosphamide-methotrexate-fluorouracil (CMF) or doxorubicin-based chemotherapy in conjunction with breast irradiation between 1968 and 1985. The overall cosmetic results were evaluated by the physician as "excellent," "good," "fair," or "poor" using a standardized scale. The CT group consisted of 170 patients treated with CT and RT administered either concurrently or sequentially (CT before RT, after RT, or both) with a minimum of 24 months of cosmetic follow-up. These were compared to an RT alone control group of 170 patients who did not receive CT and were matched by tumor size, radiation technique, and year of treatment. At 36 months, the cosmetic scores for the CT group compared to RT alone were 47% versus 71% excellent (p less than 0.01), 36% versus 19% good, and 17% versus 9% fair or poor. For the 50 patients treated with concurrent CMF and RT, the scores were 31% excellent, 45% good, and 24% fair/poor, whereas for the 118 patients treated with sequential RT and CT they were 54%, 31%, and 14%, respectively. There was no difference between those patients who received sequential CMF and those treated with doxorubicin. We conclude that adjuvant chemotherapy adversely affects the cosmetic outcome of breast irradiation, but that this effect is not clinically significant unless CMF is administered concurrently with RT. Patients treated with either sequential CMF or doxorubicin-based CT had only a slight decrement in their cosmetic result compared to patients treated without CT.

The likelihood of radiation pneumonitis and factors associated with its development in breast cancer patients treated with conservative surgery and radiation therapy have not been well established. To assess these, we retrospectively reviewed 1624 patients treated between 1968 and 1985. Median follow-up for patients without local or distant failure was 77 months. Patients were treated with either tangential fields alone ( n = 508) or tangents with a third field to the supraclavicular (SC) or SC-axillary (AX) region ( n = 1116). Lung volume treated in the tangential fields was generally limited by keeping the perpendicular distance (demagnified) at the isocenter from the deep field edges to the posterior chest wall (CLD) to 3 cm or less. Seventeen patients with radiation pneumonitis were identified (1.0%). Radiation pneumonitis was diagnosed when patients presented with cough (1517, 88%), fever (917,53%), and/or dyspnea (617,35%) and radiographic changes (1717) following completion of RT. Radiographic infiltrates corresponded to treatment portals in all patients, and in 12 of the 17 patients, returned to baseline within 1–12 months. Five patients had permanent scarring on chest X ray. No patient had late or persistent pulmonary symptoms. The incidence of radiation pneumonitis was correlated with the combined use of chemotherapy (CT) and a third field. Three percent (11/328) of patients treated with a 3-field technique who received chemotherapy developed radiation pneumonitis compared to 0.5% (6 of 1296) for all other patients ( p = 0.0001). When patients treated with a 3-field technique received chemotherapy concurrently with radiation therapy, the incidence of radiation pneumonitis was 8.8% (892) compared with 1.3% (3236) for those who received sequential chemotherapy and radiation therapy ( p = 0.002). A casexontrol analysis was performed to determine if the volume of lung irradiated (as determined using central lung distance [CLD]) was related to the risk of developing radiation pneumonitis. Three control patients were matched to each case of radiation pneumonitis based on age, side of lesion, chemotherapy (including sequencing), use of a third field, and year treated. Lung volumes were similar in the radiation pneumonitis cases and controls. We conclude that radiation pneumonitis following conservative surgery and radiation therapy for breast cancer is a rare complication, and that it is more likely to occur in patients treated with both a 3-field technique and chemotherapy (particularly given concurrently with radiation therapy). Over the limited range of volumes treated, lung volume was not associated with an increased risk of radiation pneumonitis.

7572 Background: To assess surgical, histopathologic and patient-related factors associated with local, distant and overall recurrence in patients with Stages I-IIIA Non-Small Cell Cancer (NSCLC) w...

7536 Background: Node postive presentations of Bronchioloalveolar Carcinoma are quite rare. The purpose of our investigation is to assess whether disease-specific survival (DSS) and overall surviva...