- Email: [email protected]
External Beam Radiotherapy in the Management of Recurrent I-131 Refractory Thyroid Cancer
Proceedings of the 50th Annual ASTRO Meeting Materials/Methods: 29 cases with hypopharyngeal carcinoma and 20 cases with adjacent normal mucous epithelia were evaluated with immunohistochemical assessment of EGFR, NM23 and Bcl-2 by use of formalin-fixed paraffin-embedded tissue array slides. The relationship with the clinical pathology risks of hypopharyngeal carcinoma was explored. Among these cases, 18 were originated from pyriform sinus, 9 from posterior pharyngeal wall and 2 from postcricoid area. Results: The expression of EGFR, NM23 and Bcl-2 were observed higher in hypopharyngeal cancer than in adjacent normal tissues, respectively (p \ 0.05). The EGFR in poor differentiation cancer was significantly higher than that in high/moderate differentiation cancer(p = 0.0169); The expression of EGFR in the group without lymph node metastasis was significantly lower than that in the groups with unilateral and bilateral lymph node metastasis(p = 0.0242).The expression of NM23 in cases with lymph node metastasis were lower than those without, but no statistical difference(p = 1.0). The expression of Bcl-2 in high differentiation cancer was significantly higher than that in poor differentiation cancer (p = 0.0421). Conclusions: The expression of EFGR in hypopharyngeal cancer was correlated with the pathological differentiation and lymph node metastasis. So EFGR may be the potential biomarker for assessing hypopharyngeal cancer. NM23 and Bcl-2 need be further warranted. Author Disclosure: Q. Yang, None; J. Yang, None; W. Fu, None; T. Zhang, None; Y. Wang, None; W. Liu, None.
2518
Atlas Based Auto-segmentation of CT Images: Clinical Evaluation of using Auto-contouring in High-dose, High-precision Radiotherapy of Cancer in the Head and Neck
P. C. Levendag1, M. Hoogeman1, D. Teguh1, T. Wolf2, L. Hibbard2, O. Wijers3, B. Heijmen1, P. Nowak1, E. Vasquez-Osorio1, X. Han2 1 Erasmus MC/Daniel den Hoed Cancer Center, Rotterdam, Netherlands, 2CMS, St Louis, MO, 3Radiotherapeutic Institute Friesland, Leeuwaarden, Netherlands
Purpose/Objective(s): High-dose, high precision radiotherapy (IMRT) of tumors in the H&N requires accurate delineation of target volumes and critical normal tissues. For standardization purposes, a previously developed CT-based atlas of the neck was used. Contouring of the target and the OARs, remains tedious and time consuming and suffers from large intra- and inter-observer variabilities. A promising new tool is auto-contouring by multiple subject atlas-based auto-segmentation (ABAS) of CT-images. This study discusses preliminary results regarding the accuracy and time reduction of auto-contouring. Materials/Methods: Ten N0/N+ patients were selected. In all patients the neck levels I-V (both necks), and 20 OARs (chewing muscles, swallowing muscles, parotid- and submandibular glands) were contoured, by a senior resident and corrected by the supervisor. Total contouring time was recorded. The reference contours were regarded as the gold standard and used as input for ABAS. In addition, 2 experienced observers contoured same structures in 4 of 10 patients (2 Tonsillar Fossa, 1 Base of Tongue and 1 Nasopharynx) and contouring times were recorded. Multi-subject ABAS was used to generate auto-contours of all structures. The CT images of the patient subject to the auto-segmentation was excluded form the multi-subject ABAS (leave-one-out method). Both supervisor and observer edited the auto-contours, with editing times recorded. Dice coefficient (0 indicates no overlap, 1 indicates perfect agreement) and surface-to-surface distances (STSD) were calculated to quantify the similarity to the gold standard of the contoured-, the auto-contoured- and the edited structures. Results: The mean Dice coefficient / STSD (mm) for the non-edited auto-contours were 0.6/3.5, 0.7/1.9, 0.5/2.3 and 0.7/1.6, for the neck levels, salivary glands, swallowing- and chewing muscles, respectively. The mean Dice coefficient/STSD (mm) for the observer contours was 0.7/2.1, 0.8/1.2, 0.5/2.4 and 0.8/1.2, respectively. The initial contouring times were substantial (supervisor and observer approximately 180 minutes per patient. After editing the auto-contours, Dice coefficient/STSD (mm) were 0.7/2.6, 0.8/ 1.6, 0.5/2.0 and 0.8/1.1, respectively for the neck levels, salivary glands, swallowing- and chewing muscles, respectively. The editing contouring times were approximately 53 minutes. The mean editing time for neck levels, salivary glands, swallowing- and chewing muscles was 25, 7, 7, and 14 min, respectively. Conclusions: Multiple subject ABAS of CT images proved to be a useful novel tool in rapid delineation of target and normal tissues. Although editing of the auto-contours is inevitable, (53 min), substantial time reduction was achieved. Author Disclosure: P.C. Levendag, None; M. Hoogeman, None; D. Teguh, None; T. Wolf, None; L. Hibbard, None; O. Wijers, None; B. Heijmen, None; P. Nowak, None; E. Vasquez-Osorio, None; X. Han, None.
2519
External Beam Radiotherapy in the Management of Recurrent I-131 Refractory Thyroid Cancer
G. A. Payne, G. W. Warren, J. Valentino, T. J. Gal, S. M. Arnold, K. B. Ain, D. Kenady, D. Sloan, M. R. Kudrimoti University of Kentucky, Lexington, KY Purpose/Objective(s): Traditional management of thyroid cancer involves surgery and postoperative I-131 for treatment of residual disease. In patients developing I-131 refractory thyroid cancer, external beam radiotherapy is useful in the adjuvant setting to maintain locoregional control. Presented herein is a retrospective review of initially I-131 avid thyroid cancer patients who developed I-131 refractory disease treated with EBRT at the time of recurrence. Materials/Methods: A retrospective review was performed of patients presenting to the University of Kentucky Department of Radiation Medicine with thyroid cancer between 1992 and 2007. Clinical presentation, treatment, response, survival, and toxicity (using NCI CTAE criteria) are reported. Results: Twenty-seven patients with initially I-131 avid thyroid cancer with I-131 refractory recurrence were treated with EBRT for locoregional disease. The median age at initial diagnosis was 40 (range, 12-77) and at recurrence was 47 (range, 15-87). The median interval between diagnosis and treatment with EBRT was 4 years (range, 0-21). Patient characteristics demonstrated 59% were female, 89% were papillary histology, 11% were follicular histology, 63% were Stage I, 4% were Stage II, 7% were Stage III, and 22% were Stage IV (4% were unknown stage at diagnosis). Twenty patients (74%) were node positive and 2 patients (7%) had metastatic disease at the time of diagnosis. All patients were treated with postoperative I-131 with a median total I-131 dose of 366 mCi (range, 108-1470 mCi), median dose per treatment of 184 mCi (range, 99-576 mCi, doses of \30 mCi were excluded and
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considered to be diagnostic), with a median of 2 I-131 treatments per patient (range, 1-7). All patients were treated with EBRT to a median dose of 63 Gy (range, 30-71 Gy) using 3-D based planning. Complete response was noted in 20 patient (74%), partial response in 2 (7%), persistent disease in 1 (4%); no response in 1 (4%), and unknown response in 1 (4%). Grade 3 acute toxicity was noted in 30% of patients, while Grade 4 acute toxicity was observed in 18%. Esophageal strictures developed in 5 patients (18%, 4 confirmed, 1 suspected). With a median follow-up of 27 months (range, 0-106 months), locoregional control was maintained in 20 patients (74%). Conclusions: In patients presenting with initial I-131 avid thyroid cancer and developing I-131 refractory disease, EBRT is an effective method of maintaining locoregional control with tolerable acute and late toxicity. Author Disclosure: G.A. Payne, None; G.W. Warren, None; J. Valentino, None; T.J. Gal, None; S.M. Arnold, None; K.B. Ain, None; D. Kenady, None; D. Sloan, None; M.R. Kudrimoti, None.
2520
A Randomized Trial on Dose Response in Radiotherapy for Early Glottic Cancer
J. L. Knegjens, N. F. Antonini, C. R. N. Rasch, H. Bartelink The Netherlands Cancer Institute, Amsterdam, Netherlands Purpose/Objective(s): Radiotherapy is the treatment of choice for early-stage glottic cancer, combining high cure rate with preservation of laryngeal function and voice. Despite this, uncertainty still exists about the optimal radiation dose. We conducted a prospective randomized trial to evaluate the tumor control rate and toxicity of a radiation dose of 60 Gy compared to a regimen of 66 Gy. Materials/Methods: Patients with T1-2N0M0 squamous cell carcinoma of the glottic larynx were eligible. Patients with bilateral involvement, simultaneous supra- and subglottic extension or impaired cord mobility were excluded. The total dose was 60 Gy in 30 fractions for the low-dose arm and 66 Gy in 33 fractions for the high-dose arm. Patients were irradiated 5 times a week. Acute and late toxicity were scored during radiotherapy and at each follow-up visit. Assessment of tumor response was done at the end of the radiation period, 6 weeks after radiotherapy and at each follow-up visit. Results: Between 1988 and 1997, 177 patients were included in the trial, 88 patients in the high-dose arm and 89 in the low-dose arm. T stage distribution was T1 90% and T2 10%. Baseline characteristics did not differ between the two groups. After a median follow-up of 112 months a total of 41 local failures were observed, 24 in the low-dose arm and 17 in the high-dose arm. The 5-year local recurrence free rate was 71.5% (95% CI, 66.8 - 81.9) for the low dose arm and 79.8% (95% CI, 71.7 - 88.9) for the high dose arm (p = 0.21). There was no significant difference between the low-dose and high-dose arm in the 5-year disease-free survival (63.8% (95% CI, 54.5-74.7) vs. 66.4% (95% CI, 57.1-77.2), p = 0.60) and overall survival (81.3% (95% CI, 73.4-90) vs. 85.8% (95% CI, 78.7-93.6), p = 0.16). In a multivariable analysis including age, gender, performance score, differentiation grade and T stage as covariates, T2 stage showed the only significant association for decrease of local control and overall survival (HR 6.57, p = 0.0012, respectively, HR 4.44, p = 0.003) whereas treatment arm did not (HR 1.14, p = 0.76, respectively, HR 2.16, p = 0.054). Overall, the treatment was well tolerated. Most cases of acute toxicity were mild and there was no significant difference between the two treatment groups. Treatment was interrupted in 20 patients (8 in the high-dose group and 12 in the low-dose arm) and was definitely stopped in 1 patient in the high-dose arm. Severe late complications were rare (\1%), but an increase in Grade I-II laryngeal complications was reported in the high-dose arm (56% vs. 37%, p = 0.022). Conclusions: A higher radiation dose of 66 Gy reduced the number of local recurrences, although this difference was not statistically significant. Besides an increase in mild late laryngeal toxicity, the incidence of acute and late side effects did not differ between the two treatment groups. Author Disclosure: J.L. Knegjens, None; N.F. Antonini, None; C.R.N. Rasch, None; H. Bartelink, None.
2521
Pathologic Predictors for Outcome in Recurrent and Second Primary Head and Neck Cancer Patients Undergoing Surgery followed by Concurrent Chemo-reirradiation
A. Solanki, K. Stenson, D. Haraf, K. Choe, E. Cohen, T. Seiwert, E. Blair, E. Vokes, J. K. Salama University of Chicago, Chicago, IL Purpose/Objective(s): Adjuvant concurrent chemo-reirradiation (CRRT) has been shown to improve disease free survival in previously radiated patients with recurrent or second primary head and neck cancer. We sought to identify pathologic prognostic factors for this patient cohort. Materials/Methods: 41 patients with squamous cell cancer (M0) who underwent macroscopically complete surgical resection prior to CRRT with full pathologic information were identified as a subgroup of 166 patients who underwent CRRT for recurrent or second primary head and neck cancer. CRRT was most often based on the 5-FU, hydroxyurea, and radiotherapy platform. High risk pathologic factors including positive margins, lymph node involvement, lymphovascular involvement, named nerve involvement, tumor size, soft tissue extension, periosteal involvement, carotid involvement, and extranodal extension were analyzed to determine their impact on locoregional control (LRC), disease free survival (DFS), freedom from distant metastases (FFDM), and overall survival (OS). Results: Median follow-up for all patients was 13.5 months (range, 0.3-116 mo). Median reirradiation dose was 60 Gy (range, 1074Gy), and median lifetime RT dose was 128.5 Gy. 17 patients (41.5%) received daily and 24 (58.5%) twice daily radiotherapy. On univariate analysis, carotid sheath involvement was associated with worse local control (2 year local control 78% vs. 0%, p = 0.043) as well as overall survival (2 year OS 41% vs. 0%, p = 0.056). Soft tissue deposits in the surgical specimen were associated with a significantly increased probability of distant recurrence (2 year FFDM 45% vs. 88%, p = 0.01), while positive margins (p = 0.078) and extranodal extension (p = 0.051) trended towards worse distant control. No factors were identified that predicted for disease free survival. On multivariate analysis for distant failure soft tissue extension was associated with an increased risk of distant recurrence (HR: 8.5, 95% CI: 1.4-52.9, p = 0.021). Conclusions: Carotid sheath involvement predicts for worse local control and overall survival. Patients with soft tissue deposits identified in surgical specimens prior to a course of CRRT are at higher risk for distant recurrence.
2518
Atlas Based Auto-segmentation of CT Images: Clinical Evaluation of using Auto-contouring in High-dose, High-precision Radiotherapy of Cancer in the Head and Neck
P. C. Levendag1, M. Hoogeman1, D. Teguh1, T. Wolf2, L. Hibbard2, O. Wijers3, B. Heijmen1, P. Nowak1, E. Vasquez-Osorio1, X. Han2 1 Erasmus MC/Daniel den Hoed Cancer Center, Rotterdam, Netherlands, 2CMS, St Louis, MO, 3Radiotherapeutic Institute Friesland, Leeuwaarden, Netherlands
Purpose/Objective(s): High-dose, high precision radiotherapy (IMRT) of tumors in the H&N requires accurate delineation of target volumes and critical normal tissues. For standardization purposes, a previously developed CT-based atlas of the neck was used. Contouring of the target and the OARs, remains tedious and time consuming and suffers from large intra- and inter-observer variabilities. A promising new tool is auto-contouring by multiple subject atlas-based auto-segmentation (ABAS) of CT-images. This study discusses preliminary results regarding the accuracy and time reduction of auto-contouring. Materials/Methods: Ten N0/N+ patients were selected. In all patients the neck levels I-V (both necks), and 20 OARs (chewing muscles, swallowing muscles, parotid- and submandibular glands) were contoured, by a senior resident and corrected by the supervisor. Total contouring time was recorded. The reference contours were regarded as the gold standard and used as input for ABAS. In addition, 2 experienced observers contoured same structures in 4 of 10 patients (2 Tonsillar Fossa, 1 Base of Tongue and 1 Nasopharynx) and contouring times were recorded. Multi-subject ABAS was used to generate auto-contours of all structures. The CT images of the patient subject to the auto-segmentation was excluded form the multi-subject ABAS (leave-one-out method). Both supervisor and observer edited the auto-contours, with editing times recorded. Dice coefficient (0 indicates no overlap, 1 indicates perfect agreement) and surface-to-surface distances (STSD) were calculated to quantify the similarity to the gold standard of the contoured-, the auto-contoured- and the edited structures. Results: The mean Dice coefficient / STSD (mm) for the non-edited auto-contours were 0.6/3.5, 0.7/1.9, 0.5/2.3 and 0.7/1.6, for the neck levels, salivary glands, swallowing- and chewing muscles, respectively. The mean Dice coefficient/STSD (mm) for the observer contours was 0.7/2.1, 0.8/1.2, 0.5/2.4 and 0.8/1.2, respectively. The initial contouring times were substantial (supervisor and observer approximately 180 minutes per patient. After editing the auto-contours, Dice coefficient/STSD (mm) were 0.7/2.6, 0.8/ 1.6, 0.5/2.0 and 0.8/1.1, respectively for the neck levels, salivary glands, swallowing- and chewing muscles, respectively. The editing contouring times were approximately 53 minutes. The mean editing time for neck levels, salivary glands, swallowing- and chewing muscles was 25, 7, 7, and 14 min, respectively. Conclusions: Multiple subject ABAS of CT images proved to be a useful novel tool in rapid delineation of target and normal tissues. Although editing of the auto-contours is inevitable, (53 min), substantial time reduction was achieved. Author Disclosure: P.C. Levendag, None; M. Hoogeman, None; D. Teguh, None; T. Wolf, None; L. Hibbard, None; O. Wijers, None; B. Heijmen, None; P. Nowak, None; E. Vasquez-Osorio, None; X. Han, None.
2519
External Beam Radiotherapy in the Management of Recurrent I-131 Refractory Thyroid Cancer
G. A. Payne, G. W. Warren, J. Valentino, T. J. Gal, S. M. Arnold, K. B. Ain, D. Kenady, D. Sloan, M. R. Kudrimoti University of Kentucky, Lexington, KY Purpose/Objective(s): Traditional management of thyroid cancer involves surgery and postoperative I-131 for treatment of residual disease. In patients developing I-131 refractory thyroid cancer, external beam radiotherapy is useful in the adjuvant setting to maintain locoregional control. Presented herein is a retrospective review of initially I-131 avid thyroid cancer patients who developed I-131 refractory disease treated with EBRT at the time of recurrence. Materials/Methods: A retrospective review was performed of patients presenting to the University of Kentucky Department of Radiation Medicine with thyroid cancer between 1992 and 2007. Clinical presentation, treatment, response, survival, and toxicity (using NCI CTAE criteria) are reported. Results: Twenty-seven patients with initially I-131 avid thyroid cancer with I-131 refractory recurrence were treated with EBRT for locoregional disease. The median age at initial diagnosis was 40 (range, 12-77) and at recurrence was 47 (range, 15-87). The median interval between diagnosis and treatment with EBRT was 4 years (range, 0-21). Patient characteristics demonstrated 59% were female, 89% were papillary histology, 11% were follicular histology, 63% were Stage I, 4% were Stage II, 7% were Stage III, and 22% were Stage IV (4% were unknown stage at diagnosis). Twenty patients (74%) were node positive and 2 patients (7%) had metastatic disease at the time of diagnosis. All patients were treated with postoperative I-131 with a median total I-131 dose of 366 mCi (range, 108-1470 mCi), median dose per treatment of 184 mCi (range, 99-576 mCi, doses of \30 mCi were excluded and
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considered to be diagnostic), with a median of 2 I-131 treatments per patient (range, 1-7). All patients were treated with EBRT to a median dose of 63 Gy (range, 30-71 Gy) using 3-D based planning. Complete response was noted in 20 patient (74%), partial response in 2 (7%), persistent disease in 1 (4%); no response in 1 (4%), and unknown response in 1 (4%). Grade 3 acute toxicity was noted in 30% of patients, while Grade 4 acute toxicity was observed in 18%. Esophageal strictures developed in 5 patients (18%, 4 confirmed, 1 suspected). With a median follow-up of 27 months (range, 0-106 months), locoregional control was maintained in 20 patients (74%). Conclusions: In patients presenting with initial I-131 avid thyroid cancer and developing I-131 refractory disease, EBRT is an effective method of maintaining locoregional control with tolerable acute and late toxicity. Author Disclosure: G.A. Payne, None; G.W. Warren, None; J. Valentino, None; T.J. Gal, None; S.M. Arnold, None; K.B. Ain, None; D. Kenady, None; D. Sloan, None; M.R. Kudrimoti, None.
2520
A Randomized Trial on Dose Response in Radiotherapy for Early Glottic Cancer
J. L. Knegjens, N. F. Antonini, C. R. N. Rasch, H. Bartelink The Netherlands Cancer Institute, Amsterdam, Netherlands Purpose/Objective(s): Radiotherapy is the treatment of choice for early-stage glottic cancer, combining high cure rate with preservation of laryngeal function and voice. Despite this, uncertainty still exists about the optimal radiation dose. We conducted a prospective randomized trial to evaluate the tumor control rate and toxicity of a radiation dose of 60 Gy compared to a regimen of 66 Gy. Materials/Methods: Patients with T1-2N0M0 squamous cell carcinoma of the glottic larynx were eligible. Patients with bilateral involvement, simultaneous supra- and subglottic extension or impaired cord mobility were excluded. The total dose was 60 Gy in 30 fractions for the low-dose arm and 66 Gy in 33 fractions for the high-dose arm. Patients were irradiated 5 times a week. Acute and late toxicity were scored during radiotherapy and at each follow-up visit. Assessment of tumor response was done at the end of the radiation period, 6 weeks after radiotherapy and at each follow-up visit. Results: Between 1988 and 1997, 177 patients were included in the trial, 88 patients in the high-dose arm and 89 in the low-dose arm. T stage distribution was T1 90% and T2 10%. Baseline characteristics did not differ between the two groups. After a median follow-up of 112 months a total of 41 local failures were observed, 24 in the low-dose arm and 17 in the high-dose arm. The 5-year local recurrence free rate was 71.5% (95% CI, 66.8 - 81.9) for the low dose arm and 79.8% (95% CI, 71.7 - 88.9) for the high dose arm (p = 0.21). There was no significant difference between the low-dose and high-dose arm in the 5-year disease-free survival (63.8% (95% CI, 54.5-74.7) vs. 66.4% (95% CI, 57.1-77.2), p = 0.60) and overall survival (81.3% (95% CI, 73.4-90) vs. 85.8% (95% CI, 78.7-93.6), p = 0.16). In a multivariable analysis including age, gender, performance score, differentiation grade and T stage as covariates, T2 stage showed the only significant association for decrease of local control and overall survival (HR 6.57, p = 0.0012, respectively, HR 4.44, p = 0.003) whereas treatment arm did not (HR 1.14, p = 0.76, respectively, HR 2.16, p = 0.054). Overall, the treatment was well tolerated. Most cases of acute toxicity were mild and there was no significant difference between the two treatment groups. Treatment was interrupted in 20 patients (8 in the high-dose group and 12 in the low-dose arm) and was definitely stopped in 1 patient in the high-dose arm. Severe late complications were rare (\1%), but an increase in Grade I-II laryngeal complications was reported in the high-dose arm (56% vs. 37%, p = 0.022). Conclusions: A higher radiation dose of 66 Gy reduced the number of local recurrences, although this difference was not statistically significant. Besides an increase in mild late laryngeal toxicity, the incidence of acute and late side effects did not differ between the two treatment groups. Author Disclosure: J.L. Knegjens, None; N.F. Antonini, None; C.R.N. Rasch, None; H. Bartelink, None.
2521
Pathologic Predictors for Outcome in Recurrent and Second Primary Head and Neck Cancer Patients Undergoing Surgery followed by Concurrent Chemo-reirradiation
A. Solanki, K. Stenson, D. Haraf, K. Choe, E. Cohen, T. Seiwert, E. Blair, E. Vokes, J. K. Salama University of Chicago, Chicago, IL Purpose/Objective(s): Adjuvant concurrent chemo-reirradiation (CRRT) has been shown to improve disease free survival in previously radiated patients with recurrent or second primary head and neck cancer. We sought to identify pathologic prognostic factors for this patient cohort. Materials/Methods: 41 patients with squamous cell cancer (M0) who underwent macroscopically complete surgical resection prior to CRRT with full pathologic information were identified as a subgroup of 166 patients who underwent CRRT for recurrent or second primary head and neck cancer. CRRT was most often based on the 5-FU, hydroxyurea, and radiotherapy platform. High risk pathologic factors including positive margins, lymph node involvement, lymphovascular involvement, named nerve involvement, tumor size, soft tissue extension, periosteal involvement, carotid involvement, and extranodal extension were analyzed to determine their impact on locoregional control (LRC), disease free survival (DFS), freedom from distant metastases (FFDM), and overall survival (OS). Results: Median follow-up for all patients was 13.5 months (range, 0.3-116 mo). Median reirradiation dose was 60 Gy (range, 1074Gy), and median lifetime RT dose was 128.5 Gy. 17 patients (41.5%) received daily and 24 (58.5%) twice daily radiotherapy. On univariate analysis, carotid sheath involvement was associated with worse local control (2 year local control 78% vs. 0%, p = 0.043) as well as overall survival (2 year OS 41% vs. 0%, p = 0.056). Soft tissue deposits in the surgical specimen were associated with a significantly increased probability of distant recurrence (2 year FFDM 45% vs. 88%, p = 0.01), while positive margins (p = 0.078) and extranodal extension (p = 0.051) trended towards worse distant control. No factors were identified that predicted for disease free survival. On multivariate analysis for distant failure soft tissue extension was associated with an increased risk of distant recurrence (HR: 8.5, 95% CI: 1.4-52.9, p = 0.021). Conclusions: Carotid sheath involvement predicts for worse local control and overall survival. Patients with soft tissue deposits identified in surgical specimens prior to a course of CRRT are at higher risk for distant recurrence.