Publications by authors named "Roy H Decker"

116 Publications

Brachytherapy and non-cancer mortality in patients with oral cavity and oropharynx SCCs.

Oral Oncol 2021 11 20;122:105585. Epub 2021 Oct 20.

Department of Medicine and Yale Cancer Center, Yale School of Medicine, New Haven, CT, United States.

Background: Oral cavity and oropharyngeal squamous cell cancers (OC-OPSCC) display high cancer-specific mortality and increased non-cancer mortality. We examined cause of death in patients treated for OC-OPSCC with brachytherapy, chemotherapy, external beam radiation, surgery, or combination of modalities. We hypothesized that brachytherapy does not increase non-cancer mortality comparably with external beam radiation.

Methods: A database was constructed from institutional tumor registry and electronic medical record data from all patients with first OC-OPSCC diagnosis at our institution between 2000 and 2010, excluding patients with a second primary cancer at diagnosis. The primary outcome was association between treatment modality and non-cancer mortality.

Results: Of 693 eligible patients, 460 were deceased; 84 from primary malignancy and 96 from a non-primary cancer cause, including 24 with a second primary cancer. 193 patients received brachytherapy. Cox proportional hazards regression was performed on treatment regimen, stratified by AJCC stage, race, and sex. Age, smoking history, and alcohol had HRs for death of 1.05 (p < 0.005), 1.37 (p = 0.106), and 2.24 (p < 0.005), respectively, while brachytherapy had a 0.53 HR (p < 0.005) for death. Non-smoking OPC patients had an 88% 5-year OS, suggesting these were largely HPV-driven cancers. In smoking OPC patients, 5-year OS was 61%. Non-cancer mortality HR of 0.36 for brachytherapy-treated patients.

Conclusion: We report non-cancer mortality from a cohort of curatively treated OC-OPSCC and show a significant correlation between brachytherapy and non-cancer survival, independent of remission status. The impact of brachytherapy in OPC was strongest in smokers.
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http://dx.doi.org/10.1016/j.oraloncology.2021.105585DOI Listing
November 2021

Post-operative radiation therapy for non-small cell lung cancer: A comparison of radiation therapy techniques.

Lung Cancer 2021 11 20;161:171-179. Epub 2021 Sep 20.

Department of Therapeutic Radiology, Yale University School of Medicine, New Haven, CT, USA; Cancer Outcomes, Public Policy, and Effectiveness Research (COPPER) Center, Yale School of Medicine, New Haven, CT, USA.

Objectives: Post-operative radiation therapy (PORT) in locally advanced non-small cell lung cancer (LA-NSCLC) has historically been associated with toxicity. Conformal techniques like intensity modulated radiation therapy (IMRT) have the potential to reduce acute and long-term toxicity from radiation therapy. Among patients receiving PORT for LA-NSCLC, we identified factors associated with receipt of IMRT and evaluated the association between IMRT and toxicity.

Methods: We queried the Surveillance, Epidemiology, and End Results (SEER)-Medicare database between January 1, 2006 to December 31, 2014 to identify patients diagnosed with Stage II or III NSCLC and who received upfront surgery and subsequent PORT. Baseline differences between patients receiving 3-dimentional conformal radiation therapy (3D-CRT) and IMRT were assessed using the chi-squared test for proportions and the t-test for means. Multivariable logistic regression was used to identify predictors of receipt of IMRT and pulmonary, esophageal, and cardiac toxicity. Propensity-score matching was employed to reduce the effect of known confounders.

Results: A total of 620 patients met the inclusion criteria, among whom 441 (71.2%) received 3D-CRT and 179 (28.8%) received IMRT. The mean age of the cohort was 73.9 years and 54.7% were male. The proportion of patients receiving IMRT increased from 6.2% in 2006 to 41.4% in 2014 (P < 0.001). IMRT was not associated with decreased pulmonary (OR 0.89; 95% CI, 0.62-1.29), esophageal (OR 1.09; 95% CI, 0.0.75-1.58), or cardiac toxicity (OR 1.02; 95% CI, 0.69-1.51). These findings held on propensity-score matching. Clinical risk factors including comorbidity and prior treatment history were associated with treatment toxicity.

Conclusion: In a cohort of elderly patients, the use of IMRT in the setting of PORT for LA-NSCLC was not associated with a difference in toxicity compared to 3D-CRT. This finding suggests that outcomes from PORT may be independent of radiotherapy treatment technique.
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http://dx.doi.org/10.1016/j.lungcan.2021.09.010DOI Listing
November 2021

Optimal Radiation Dose for Stage III Lung Cancer-Should "Definitive" Radiation Doses Be Used in the Preoperative Setting?

JTO Clin Res Rep 2021 Aug 24;2(8):100201. Epub 2021 Jun 24.

Section of Thoracic Surgery, Department of Surgery, Yale School of Medicine, New Haven, Connecticut.

Introduction: There are currently two recommended radiation strategies for clinical stage III NSCLC: a lower "preoperative" (45-54 Gy) and a higher "definitive/nonsurgical" (60-70 Gy) dose. We sought to determine if definitive radiation doses should be used in the preoperative setting given that many clinical stage III patients planned for surgery are ultimately managed with chemoradiation alone.

Methods: Using the National Cancer Database data from 2006 to 2016, we performed a comparative effectiveness analysis of stage III N2 patients who received chemoradiotherapy. Patients were stratified into subgroups across 2 parameters: (1) radiation dose: lower (45-54 Gy) and higher (60-70 Gy); and (2) the use of surgery (i.e., surgical and nonsurgical treatment approaches). Long-term survival and perioperative outcomes were evaluated using multivariable Cox proportional hazards and logistic regression models.

Results: A cohort of 961 patients received radiation before surgery including 321 who received a higher dose and 640 who received a lower dose. A higher preoperative dose revealed similar long-term mortality risk (hazard ratio = 0.99, 95% confidence interval: 0.82-1.21,  = 0.951) compared with a lower dose. There was no significant association between radiation dose and 90-day mortality ( = 0.982), 30-day readmission ( = 0.931), or prolonged length of stay ( = 0.052) in the surgical cohort. A total of 17,904 clinical-stage IIIA-N2 patients were treated nonsurgically, including 15,945 receiving higher and 1959 treated with a lower dose. A higher dose was associated with a reduction in long-term mortality risk (hazard ratio = 0.64, 95% confidence interval: 0.60-0.67, < 0.001) compared with a lower dose.

Conclusions: For clinical stage III NSCLC, the administration of 60 to 70 Gy of radiation seems to be more effective than the lower dose for nonsurgical patients without compromising surgical safety for those that undergo resection. This evidence supports the implementation of 60 to 70 Gy as a single-dose strategy for both preoperative and definitive chemoradiotherapy.
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http://dx.doi.org/10.1016/j.jtocrr.2021.100201DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8474436PMC
August 2021

Rates of invasive disease and outcomes in NSCLC patients with biopsy suggestive of carcinoma in situ.

Lung Cancer 2021 07 26;157:17-20. Epub 2021 May 26.

Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.

Introduction: Carcinoma in situ is a rare non-invasive histology of non-small cell lung cancer (NSCLC) with excellent survival outcomes with resection. However, management of lung biopsy suggestive of in situ disease remains unclear. To inform decision-making in this scenario, we determined the rate of invasive disease presence upon resection of lesions with an initial biopsy suggestive of purely in situ disease.

Methods: The study included 960 patients diagnosed with NSCLC from 2003 to 2017 in the National Cancer Database whose workup included a lung biopsy suggestive of in situ disease. Among the cohort who proceeded to resection, we identified the rate of invasive disease discovered on surgical pathology along with significant demographic and clinical contributors to invasion risk. Survival outcomes were measured for the observed cohort that did not receive local therapy after biopsy.

Results: Invasive disease was identified at resection in 49.3 % of patients. Lesion size was associated with risk of invasive disease: 35.7 % for ≤1 cm, 45.2 % for 1-2 cm, 55.7 % for 2-3 cm, and 87.5 % for 3-5 cm (p < 0.001). Of patients with squamous histology, 61.5 % had invasive disease versus 46.5 % with adenocarcinoma histology (p = 0.026). On multivariable logistic regression, invasive disease remained associated with tumor size (OR 1.9 per cm, 95 % CI 1.5-2.4, p < 0.001), and squamous histology (OR 1.8, 95 % CI 1.1-3.2, p = 0.028). Overall survival at 3 years was 51.5 % in the observed cohort.

Conclusion: Nearly half of patients with biopsy suggestive of in situ disease had invasive disease at resection. Tumor size and histology are strong predictors of invasive disease and may be used for risk stratification. However, the findings support the practice of definitive therapy whenever feasible.
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http://dx.doi.org/10.1016/j.lungcan.2021.05.028DOI Listing
July 2021

A Dose-finding Study Followed by a Phase II Randomized, Placebo-controlled Trial of Chemoradiotherapy With or Without Veliparib in Stage III Non-small-cell Lung Cancer: SWOG 1206 (8811).

Clin Lung Cancer 2021 07 19;22(4):313-323.e1. Epub 2021 Feb 19.

University of California Davis, Sacramento, CA.

Background: We conducted a 2-part study to evaluate the incorporation of veliparib, a PARP inhibitor, into chemoradiotherapy (CRT) for stage III non-small-cell lung cancer.

Patients And Methods: In the phase I part, patients were treated successively at 3 dose levels of veliparib (40, 80, and 120 mg) twice daily during CRT. In the phase II part, patients were randomized to receive veliparib or placebo during thoracic radiotherapy with concurrent weekly carboplatin and paclitaxel, followed by 2 cycles of consolidation carboplatin and paclitaxel with veliparib or placebo. The study was prematurely discontinued owing to the emergence of adjuvant immunotherapy as standard of care.

Results: Of 21 patients enrolled in phase I, 2 patients developed dose-limiting toxicities (DLTs): 1 grade 3 esophagitis with dysphagia (at 40 mg) and 1 grade 3 esophagitis with dehydration (at 80 mg). No DLTs were seen at veliparib dose of 120 mg twice daily, which was selected for the phase II part that enrolled 31 eligible patients. Progression-free survival (PFS) was not different between the 2 arms (P = .20). For the veliparib and placebo arms, response rates were 56% and 69%, PFS at 1 year 47% and 46%, and overall survival at 1 year 89% and 54%, respectively.

Conclusion: Veliparib with CRT was feasible and well tolerated. Efficacy could not accurately be determined because of early study closure. Nonetheless, there is enthusiasm for the evaluation of PARP inhibitors in lung cancer as predictive biomarkers are being developed and combinations with immunotherapy are attractive.
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http://dx.doi.org/10.1016/j.cllc.2021.02.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8562492PMC
July 2021

Radiation Therapy for Small-Cell Lung Cancer: ASCO Guideline Endorsement of an ASTRO Guideline.

J Clin Oncol 2021 03 27;39(8):931-939. Epub 2021 Jan 27.

University of Michigan School of Medicine, Ann Arbor, MI.

Purpose: The American Society for Radiation Oncology (ASTRO) produced an evidence-based guideline on radiation therapy (RT) for small-cell lung cancer (SCLC). Because of the relevance of this topic to ASCO membership, ASCO reviewed the guideline, applying a set of procedures and policies used to critically examine guidelines developed by other organizations.

Methods: The ASTRO guideline on RT for SCLC was reviewed for developmental rigor by methodologists. Then, an ASCO Expert Panel reviewed the content and the recommendations.

Results: The ASCO Expert Panel determined that the recommendations from ASTRO guideline on RT for SCLC, published in June 2020, are clear, thorough, and based upon the most relevant scientific evidence. ASCO endorsed ASTRO guideline on RT for SCLC with a few discussion points.

Recommendations: Recommendations addressed thoracic radiotherapy for limited-stage SCLC, role of stereotactic body radiotherapy in stage I or II node-negative SCLC, prophylactic cranial radiotherapy, and thoracic consolidation for extensive-stage SCLC.Additional information is available at www.asco.org/thoracic-cancer-guidelines.
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http://dx.doi.org/10.1200/JCO.20.03364DOI Listing
March 2021

A Blinded, Prospective Study of Error Detection During Physician Chart Rounds in Radiation Oncology.

Pract Radiat Oncol 2020 Sep - Oct;10(5):312-320

Department of Therapeutic Radiology, Yale School of Medicine, New Haven, Connecticut.

Purpose: Peer review during physician chart rounds is a major quality assurance and patient safety step in radiation oncology. However, the effectiveness of chart rounds in detecting problematic treatment plans is unknown. We performed a prospective blinded study of error detection at chart rounds to clarify the effectiveness of this quality assurance step.

Methods And Materials: Radiation Oncology Incident Learning System publications were queried for problematic plans approved for treatment that would be detectable at chart rounds. A resident physician, physicist, and dosimetrist collaboratively generated 20 treatment plans with simulated errors identical in nature to those reported to the Radiation Oncology Incident Learning System. These were inserted randomly into weekly chart rounds over 9 weeks, with a median of 2 problematic plans presented per chart rounds (range, 1-4). Data were collected on detection, attendance, length, and number of cases presented at chart rounds. Data were analyzed using descriptive statistics and univariable logistic regression with odds ratios.

Results: The median length of chart rounds over the study period was 60 minutes (range, 42-79); median number of cases presented per chart rounds was 45 (range, 38-50). The overall detection rate was 55% (11 of 20). Detection rates were higher for cases presented earlier in chart rounds: 75% versus 25% of problematic plans were detected within 30 minutes of start of chart rounds versus after 30 minutes (odds ratio, 0.11; 95% confidence interval, 0.01-0.88; P = .037). Detection rates showed a trend toward increase during the study period but this was not significant: 33% in weeks 1 to 5 and 73% during weeks 6 to 9 (5.3; 95% confidence interval, 0.78-36; P = .08).

Conclusions: The detection of clinically significant problematic plans during chart rounds could be significantly improved. Problematic plans are more frequently detected earlier in chart rounds and inserting such plans into chart rounds may enhance detection; however, larger studies are needed to confirm these findings. A multi-institutional study is planned.
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http://dx.doi.org/10.1016/j.prro.2020.05.012DOI Listing
August 2021

Multi-institutional retrospective review of stereotactic radiosurgery for brain metastasis in patients with small cell lung cancer without prior brain-directed radiotherapy.

J Radiosurg SBRT 2020 ;7(1):19-27

Department of Therapeutic Radiology, Yale School of Medicine, New Haven, CT 06511, USA.

Patients with small cell lung cancer (SCLC) brain metastasis (BM) typically receive whole brain radiotherapy (WBRT) as data regarding upfront radiosurgery (SRS) in this setting are sparse. Patients receiving SRS for SCLC BM without prior brain radiation were identified at three U.S. institutions. Overall survival (OS), freedom from intracranial progression (FFIP), freedom from WBRT (FFWBRT), and freedom from neurologic death (FFND) were determined from time of SRS. Thirty-three patients were included with a median of 2 BM (IQR 1-6). Median OS and FFIP were 6.7 and 5.8 months, respectively. Median FFIP for patients with ≤2 versus >2 BM was 7.1 versus 3.6 months, p=0.0303. Eight patients received salvage WBRT and the 6-month FFWBRT and FFND were 87.8%. and 90.1%, respectively. Most SCLC patients with BM who received upfront SRS avoided WBRT and neurologic death, suggesting that SRS may be an option in select patients.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7406345PMC
January 2020

Resident attitudes and benefits of mock oral board examinations in radiation oncology.

BMC Med Educ 2020 Jun 26;20(1):203. Epub 2020 Jun 26.

Department of Therapeutic Radiology, Yale School of Medicine, 35 Park Street, New Haven, CT 06516, USA.

Background: Presently, educational programming is not standardized across radiation oncology (RO) training programs. Specifically, there are limited materials through national organizations or structured practice exams for residents preparing for the American Board of Radiology (ABR) oral board examination. We present our 2019 experience implementing a formalized program of early mock oral board examinations (MOBE) for residents in post-graduate years (PGY) 3-5.

Methods: A mixed-methods survey regarding MOBE perception and self-reported comfort across five clinical domains were administered to PGY2-5 residents. MOBEs and a post-intervention survey were implemented for the PGY3-5. The pre and post-intervention score across clinical domains were compared using t-tests. Faculty and residents were asked for post-intervention comments.

Results: A total of 14 PGY2-5 residents completed the pre-intervention survey; 9 residents participated in the MOBE (5/14 residents were PGY2s) and post-intervention survey. This was the first mock oral radiation oncology examination experience for 65% of residents. 100% of residents felt the MOBE increased their clinical knowledge and comfort with clinical reasoning. Overall, there was a trend towards improved resident confidence giving planning dose parameters and (p = 0.08). There was also unanimous request for more MOBE experiences from residents and faculty, but time was identified as a significant barrier.

Conclusions: Future directions for this MOBE program are inclusion of more disease sites, better emulation of the exam, the creation of a more rigorous consolidated format testing all sites at once, and consideration for grading of these sessions for future correlation with certifying oral board examination (OBE) performance.
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http://dx.doi.org/10.1186/s12909-020-02106-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7318518PMC
June 2020

Local Ablative Therapies for Oligometastatic and Oligoprogressive Non-Small Cell Lung Cancer.

Cancer J 2020 Mar/Apr;26(2):129-136

From the Department of Therapeutic Radiology, Yale University School of Medicine, New Haven, CT.

More than half of all patients with non-small cell lung cancer (NSCLC) have metastatic disease at the time of diagnosis. A subset of these patients has oligometastatic disease, which exists in an intermediary state between locoregional and disseminated metastatic disease. In addition, some metastatic patients on systemic therapy may have limited disease progression, or oligoprogression. Historically, treatment of metastatic NSCLC was palliative in nature, with little expectation of long-term survival. However, an accumulation of evidence over the past 3 decades now demonstrates that local ablative therapy to sites of limited metastases or progression can improve patient outcomes for this complex disease. This review examines the evidence behind local ablative therapy in oligometastatic and oligoprogressive NSCLC, with a focus on surgery, stereotactic radiotherapy, and radiofrequency ablation.
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http://dx.doi.org/10.1097/PPO.0000000000000433DOI Listing
April 2021

Phase 1 Trial of Pembrolizumab Administered Concurrently With Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer: A Nonrandomized Controlled Trial.

JAMA Oncol 2020 06;6(6):848-855

Division of Medical Oncology, Rutgers Cancer Institute of New Jersey, Rutgers Robert Wood Johnson Medical School, Rutgers University.

Importance: Consolidative programmed death ligand-1 (PD-L) inhibition after chemoradiotherapy improves overall survival and progression-free survival (PFS) for stage III non-small cell lung cancer (NSCLC) and requires safety evaluation for incorporation of programmed cell death 1 (PD-1) inhibition at the onset of chemoradiotherapy.

Objective: To determine the safety and tolerability of PD-1 inhibition concurrently with definitive chemoradiotherapy for NSCLC.

Design, Setting, And Participants: This phase 1 prospective multicenter nonrandomized controlled trial using a 3 plus 3 design was performed from August 30, 2016, to October 24, 2018, with a median follow-up of 16.0 (95% CI, 12.0-22.6) months and data locked on July 25, 2019. Twenty-one participants had locally advanced, unresectable, stage III NSCLC as determined by multidisciplinary review, Eastern Cooperative Oncology Group performance status 0 or 1, and adequate hematologic, renal, and hepatic function. Data were analyzed from October 17, 2016, to July 19, 2019.

Interventions: Pembrolizumab was combined with concurrent chemoradiotherapy (weekly carboplatin and paclitaxel with 60 Gy of radiation in 2 Gy per d). Dose cohorts evaluated included full-dose pembrolizumab (200 mg intravenously every 3 weeks) 2 to 6 weeks after chemoradiotherapy (cohort 1); reduced-dose pembrolizumab (100 mg intravenously every 3 weeks) starting day 29 of chemoradiotherapy (cohort 2); full-dose pembrolizumab starting day 29 of chemoradiotherapy (cohort 3); reduced-dose pembrolizumab starting day 1 of chemoradiotherapy (cohort 4); and full-dose pembrolizumab starting day 1 of chemoradiotherapy (cohort 5). A safety expansion cohort of 6 patients was planned based on the maximum tolerated dose of pembrolizumab. Dose-limiting toxic effects were defined as pneumonitis of at least grade 4 within cycle 1 of pembrolizumab treatment.

Main Outcomes And Measures: Safety and tolerability of PD-1 inhibition with chemoradiotherapy for NSCLC. Secondary outcomes included PFS and pneumonitis rates.

Results: Among the 21 patients included in the analysis (11 female [52%]; median age, 69.5 [range, 53.0-85.0] years), no dose-limiting toxic effects in any cohort were observed. One case of grade 5 pneumonitis occurred in the safety expansion cohort with the cohort 5 regimen. Immune-related adverse events of at least grade 3 occurred in 4 patients (18%). Median PFS for patients who received at least 1 dose of pembrolizumab (n = 21) was 18.7 (95% CI, 11.8-29.4) months, and 6- and 12-month PFS were 81.0% (95% CI, 64.1%-97.7%) and 69.7% (95% CI, 49.3%-90.2%), respectively. Median PFS for patients who received at least 2 doses of pembrolizumab (n = 19) was 21.0 (95% CI, 15.3 to infinity) months.

Conclusions And Relevance: These findings suggest that combined treatment with PD-1 inhibitors and chemoradiotherapy for stage III NSCLC is tolerable, with promising PFS of 69.7% at 12 months, and requires further study.

Trial Registration: ClinicalTrials.gov Identifier: NCT02621398.
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http://dx.doi.org/10.1001/jamaoncol.2019.6731DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7042914PMC
June 2020

Adjuvant external beam radiotherapy for surgically resected, nonmetastatic anaplastic thyroid cancer.

Head Neck 2020 05 3;42(5):1031-1044. Epub 2020 Feb 3.

Department of Therapeutic Radiology, Yale School of Medicine, New Haven, Connecticut.

Background: EBRT in resected, nonmetastatic anaplastic thyroid cancer (ATC) remains undefined. We evaluated patterns/outcomes with EBRT and chemotherapy in this setting.

Methods: This retrospective analysis included patients identified from the National Cancer Database with nonmetastatic ATC from 2004 to 2014 who underwent non-palliative resection.

Results: Our analysis included 496 patients, including 375 who underwent adjuvant EBRT (among whom 198 received concurrent chemotherapy). The median age was 68 years. On MVA, EBRT was associated with sex (OR 0.5, 95% CI 0.3-0.8, P = .002) and income (OR 2.2, 95% CI 1.4-3.3, P < .001). EBRT was associated with longer OS on UVA (12.3 vs 9.1 months, P = .004) and MVA (HR 0.7 [CI 0.6-0.9], P = .004). Concurrent chemoradiation was associated with longer OS on UVA (14.0 vs 9.1 months, P = .003) and MVA (HR 0.6 [CI 0.5-0.8], P < .001).

Conclusion: Adjuvant EBRT is associated with longer OS in resected, nonmetastatic ATC, with additional improved survival with concurrent chemotherapy.
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http://dx.doi.org/10.1002/hed.26086DOI Listing
May 2020

Contemporary Topics in Radiation Medicine: Skin Cancer.

Hematol Oncol Clin North Am 2020 02;34(1):189-203

Department of Therapeutic Radiology, Smilow Cancer Center, Yale University, 35 Park Street, Lower Lobby, New Haven, CT 06510, USA.

Radiation plays an important role in the management of a variety of skin cancers. This article discusses the role of radiation in the treatment of cutaneous squamous cell carcinoma, basal cell carcinoma, Merkel cell carcinoma, cutaneous T-cell lymphoma, and B-cell lymphomas.
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http://dx.doi.org/10.1016/j.hoc.2019.09.008DOI Listing
February 2020

A new approach to predicting risk for N2 disease in non-small cell lung cancer.

J Thorac Dis 2019 Sep;11(Suppl 15):S1973-S1975

Department of Surgery, Yale University, New Haven, CT, USA.

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http://dx.doi.org/10.21037/jtd.2019.07.61DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6783735PMC
September 2019

SBRT for Early Stage Laryngeal Cancer: Progress, But Not Quite Ready for Prime Time.

Int J Radiat Oncol Biol Phys 2019 09;105(1):121-123

Department of Therapeutic Radiology, Yale School of Medicine, New Haven, Connecticut. Electronic address:

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http://dx.doi.org/10.1016/j.ijrobp.2019.05.021DOI Listing
September 2019

Novel Eye Plaque Designs for Brachytherapy of Iris and Ciliary Body Melanoma and the First Clinical Application.

Ocul Oncol Pathol 2019 Apr 11;5(3):220-227. Epub 2018 Oct 11.

Department of Ophthalmology and Visual Science, Yale University School of Medicine, New Haven, Connecticut, USA.

Background: While traditional eye plaque brachytherapy can be used for the treatment of iris melanoma, it faces challenges of poor patient tolerability due to cornea-plaque touch caused by radius of curvature mismatch and potential dosimetric inaccuracy from incomplete coverage. We present novel plaque designs and the first clinical application of the plaques for iris melanoma.

Methods: Two dome-shaped plaques (EP2132 and EP1930) were designed to vault above the cornea to treat tumors of the iris and ciliary body. Image-based treatment planning of the first 2 clinical cases using the EP2132 plaque covered the tumor base plus a 2 mm margin and the involved ciliary body with at least 75 Gy to the tumor apex.

Results: The tumors decreased in size following treatment. The patients tolerated the treatment well. There was no adverse event associated with the traditional iris plaques, such as decreased vision, pain, corneal edema, glaucoma, or cataract.

Conclusion: The novel dome-shaped plaques for the treatment of iris melanoma provide effective dose distribution, improved surgical maneuverability, and increased tolerability for the patient. This plaque model can be used to treat iris melanoma of various sizes, configurations, and locations, including the ciliary body. The need for a customized plaque platform for each patient is minimized.
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http://dx.doi.org/10.1159/000493269DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6489066PMC
April 2019

Multi-institutional analysis of stereotactic body radiation therapy for operable early-stage non-small cell lung carcinoma.

Radiother Oncol 2019 05 1;134:44-49. Epub 2019 Feb 1.

Department of Therapeutic Radiology, Yale University School of Medicine, New Haven, USA.

Purpose: Although stereotactic body radiation therapy (SBRT) is the standard of care for inoperable early-stage non-small cell lung carcinoma (NSCLC), its role for medically operable patients remains controversial. To address this knowledge gap, we conducted a multi-institutional study to assess post-SBRT disease control and survival outcomes in medically operable patients.

Methods: We conducted a retrospective cohort study including patients with biopsy-proven cT1-2N0M0 NSCLC treated with definitive SBRT (2006-2015). Per patient charts, inoperability referred to documentation of poor surgical candidacy with a given rationale for lack of resection. Charts of operable patients contained documentation of patients refusing surgery or choosing SBRT, without a documented rationale for inoperability. Subjects were excluded in cases of ambiguity regarding the aforementioned definitions and/or lack of clearly documented operability status. Endpoints included local failure (LF) and regional-distant failure, both evaluated with Fine and Gray competing risks regression; Kaplan-Meier methodology analyzed overall survival (OS) and progression-free survival (PFS).

Results: Of 952 patients, 408 (42.9%) were operable, and 544 (57.1%) were inoperable. Median follow-up was 22 months. Two-year LF was 9.7% in operable patients and 8.2% in inoperable patients (p = 0.36). There was no statistical difference in regional-distant failure (p = 0.55) between cohorts. Operable patients experienced statistically higher OS (p = 0.04), but not PFS (p = 0.11). Respective 1-, 2-, and 3-year OS in operable patients were 85.4%, 66.2%, and 51.2%.

Conclusions: Although patients with operable NSCLC experience higher OS than their inoperable counterparts, disease-related outcomes are similar. These results may better inform shared decision-making between medically operable patients and their multidisciplinary providers.
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http://dx.doi.org/10.1016/j.radonc.2019.01.027DOI Listing
May 2019

Stereotactic body radiotherapy with adjuvant systemic therapy for early-stage non-small cell lung carcinoma: A multi-institutional analysis.

Radiother Oncol 2019 03 31;132:188-196. Epub 2018 Oct 31.

Department of Therapeutic Radiology, Yale School of Medicine, New Haven, United States.

Purpose: Although adjuvant systemic therapy (ST) is often recommended for the treatment of patients with high-risk, early-stage non-small cell lung carcinoma (NSCLC) after surgery, there is little evidence supporting the use of ST with stereotactic body radiotherapy (SBRT).

Methods: We conducted a retrospective cohort study using a multi-institutional database to identify consecutive patients with T1-3N0M0 NSCLC treated with definitive SBRT from 2006-2015. Treatment groups were defined as those who received SBRT + ST or SBRT alone. Regional-distant failure (RDF) was analyzed with Fine and Gray competing risks regression. Progression-free (PFS) and overall survival (OS) were analyzed with the Kaplan-Meier method and Cox regression. Additional comparisons were made after 2:1 nearest-neighbor propensity-score matching on clinical risk factors.

Results: We identified 54 patients who received SBRT + ST. The most common ST regimen was a platinum doublet (n = 38; 70.4%). Compared with patients receiving SBRT (n = 1269), SBRT + ST patients were younger (median age: 70 v 77 years, p < 0.001), had larger tumors (>3 cm: 38.9% v 21.6%, p = 0.02) and higher T-stage (T2-3: 42.6% v 22.5%, p = 0.002). Compared with SBRT patients, SBRT + ST patients had lower 2-year RDF (3.1% v 16.9%, p = 0.02). On multivariable analysis, SBRT + ST was associated with reduced RDF (HR: 0.15, 95%CI: 0.04-0.62), with a trend toward improved PFS (HR: 0.70, 95%CI: 0.48-1.03), but not OS (HR: 0.74, 95%CI: 0.49-1.11). After propensity-score matching, the SBRT + ST cohort demonstrated improved RDF (HR: 0.17, 95%CI: 0.04-0.76) and PFS (HR: 0.59, 95%CI: 0.38-0.93).

Conclusion: In this multi-institutional analysis, adjuvant ST was independently associated with reduced RDF in early-stage NSCLC patients treated with SBRT.
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http://dx.doi.org/10.1016/j.radonc.2018.10.017DOI Listing
March 2019

Pretreatment Identification of Head and Neck Cancer Nodal Metastasis and Extranodal Extension Using Deep Learning Neural Networks.

Sci Rep 2018 09 19;8(1):14036. Epub 2018 Sep 19.

Department of Therapeutic Radiology, Yale School of Medicine, New Haven, USA.

Identification of nodal metastasis and tumor extranodal extension (ENE) is crucial for head and neck cancer management, but currently only can be diagnosed via postoperative pathology. Pretreatment, radiographic identification of ENE, in particular, has proven extremely difficult for clinicians, but would be greatly influential in guiding patient management. Here, we show that a deep learning convolutional neural network can be trained to identify nodal metastasis and ENE with excellent performance that surpasses what human clinicians have historically achieved. We trained a 3-dimensional convolutional neural network using a dataset of 2,875 CT-segmented lymph node samples with correlating pathology labels, cross-validated and fine-tuned on 124 samples, and conducted testing on a blinded test set of 131 samples. On the blinded test set, the model predicted ENE and nodal metastasis each with area under the receiver operating characteristic curve (AUC) of 0.91 (95%CI: 0.85-0.97). The model has the potential for use as a clinical decision-making tool to help guide head and neck cancer patient management.
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http://dx.doi.org/10.1038/s41598-018-32441-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6145900PMC
September 2018

Prophylactic Cranial Irradiation Versus Surveillance: Physician Bias and Patient-centered Decision-making.

Clin Lung Cancer 2018 11 22;19(6):464-466. Epub 2018 Aug 22.

Department of Therapeutic Radiology, Yale School of Medicine, New Haven, CT. Electronic address:

An original work in this month's issue of Clinical Lung Cancer highlights the role of physician bias in the decision to recommend prophylactic cranial irradiation (PCI) to patients with small-cell lung cancer, and presents a patient decision aid to facilitate discussion. After decades of clinical trials, we've learned that PCI can significantly decrease the risk of brain metastases and possibly improve survival. However, PCI is also associated with negative impacts on cognition and quality of life. At present, there is no consensus on how to balance these risks and benefits. Understanding and exploring these issues in a structured fashion offers an opportunity to return decision-making to patients, incorporating their values and priorities.
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http://dx.doi.org/10.1016/j.cllc.2018.08.003DOI Listing
November 2018

High Single Doses of Radiation May Induce Elevated Levels of Hypoxia in Early-Stage Non-Small Cell Lung Cancer Tumors.

Int J Radiat Oncol Biol Phys 2018 09 1;102(1):174-183. Epub 2018 Jun 1.

Department of Therapeutic Radiology, Yale University School of Medicine, New Haven, Connecticut. Electronic address:

Purpose: Tumor hypoxia correlates with treatment failure in patients undergoing conventional radiation therapy. However, no published studies have investigated tumor hypoxia in patients undergoing stereotactic body radiation therapy (SBRT). We aimed to noninvasively quantify the tumor hypoxic volume (HV) in non-small cell lung cancer (NSCLC) tumors to elucidate the potential role of tumor vascular response and reoxygenation at high single doses.

Methods And Materials: Six SBRT-eligible patients with NSCLC tumors >1 cm were prospectively enrolled in an institutional review board-approved study. Dynamic positron emission tomography images were acquired at 0 to 120 minutes, 150 to 180 minutes, and 210 to 240 minutes after injection of F-fluoromisonidazole. Serial imaging was performed prior to delivery of 18 Gy and at approximately 48 hours and approximately 96 hours after SBRT. Tumor HVs were quantified using the tumor-to-blood ratio (>1.2) and rate of tracer influx (>0.0015 mL·min·cm).

Results: An elevated and in some cases persistent level of tumor hypoxia was observed in 3 of 6 patients. Two patients exhibited no detectable baseline tumor hypoxia, and 1 patient with high baseline hypoxia only completed 1 imaging session. On the basis of the tumor-to-blood ratio, in the remaining 3 patients, tumor HVs increased on day 2 after 18 Gy and then showed variable responses on day 4. In the 3 of 6 patients with detectable hypoxia at baseline, baseline tumor HVs ranged between 17% and 24% (mean, 21%), and HVs on days 2 and 4 ranged between 33% and 45% (mean, 40%) and between 18% and 42% (mean, 28%), respectively.

Conclusions: High single doses of radiation delivered as part of SBRT may induce an elevated and in some cases persistent state of tumor hypoxia in NSCLC tumors. Hypoxia imaging with F-fluoromisonidazole positron emission tomography should be used in a larger cohort of NSCLC patients to determine whether elevated tumor hypoxia is predictive of treatment failure in SBRT.
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http://dx.doi.org/10.1016/j.ijrobp.2018.05.032DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6092043PMC
September 2018

Harnessing the Immunomodulatory Effects of Radiation Therapy.

Oncology (Williston Park) 2018 07;32(7):370-4, CV3

In this article, we discuss the immunogenicity of radiation-induced cell death and describe the innate immune signaling pathways that precede adaptive antitumoral immunity. The innate and adaptive immune systems work in concert to generate systemic immune responses. In the setting of cancer, DNA damage caused by radiotherapy activates the innate immune system while tumor cell death liberates antigen that serves as a target for adaptive immunity. The immunomodulatory effects of radiation have been investigated in preclinical models; here we summarize the available data, with particular attention to the effects of radiotherapy timing, location, dose, and fractionation strategy on the antitumoral immune response. We synthesize preclinical and clinical information regarding the potential superiority of hypofractionated radiation for induction of proinflammatory responses. Although many questions remain, early successes with combining immunotherapy and radiotherapy merit further inquiry into the dose and fractionation strategies best able to activate and sustain an antitumoral response.
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July 2018

Bullous disorders associated with anti-PD-1 and anti-PD-L1 therapy: A retrospective analysis evaluating the clinical and histopathologic features, frequency, and impact on cancer therapy.

J Am Acad Dermatol 2018 Dec 17;79(6):1081-1088. Epub 2018 Jul 17.

Department of Dermatology, Yale University School of Medicine, New Haven, Connecticut. Electronic address:

Background: Bullous disorders associated with anti-programmed cell death 1 (PD-1)/programmed cell death ligand 1 (PD-L1) therapy are increasingly reported and may pose distinct therapeutic challenges. Their frequency and impact on cancer therapy are not well established.

Objective: To evaluate the clinical and histopathologic findings, frequency, and impact on cancer therapy of bullous eruptions due to anti-PD-1/PD-L1 therapy.

Methods: We retrospectively reviewed the medical records of patients evaluated by the oncodermatology clinic and consultative service of Yale New Haven Hospital from 2016 to 2018.

Results: We identified 9 of 853 patients who developed bullous eruptions (∼1%) that were treated with an-PD-1/PD-L1 therapy at our institution during the study period: 7 presented with bullous pemphigoid, 1 presented with bullous lichenoid dermatitis, and 1 presented with linear IgA bullous dermatosis in the context of vancomycin therapy. In all, 8 patients required systemic steroids, 5 required maintenance therapy, and 8 required interruption of immunotherapy. All 9 patients had an initial positive tumor response or stable disease, but 4 went on to develop disease progression.

Limitations: This was a retrospective study from a single tertiary care center.

Conclusions: Bullous disorders developed in approximately 1% of patients treated with anti-PD-1/PD-L1 therapy at our institution and frequently resulted in interruption of immune therapy and management with systemic corticosteroids and occasionally steroid-sparing agents.
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http://dx.doi.org/10.1016/j.jaad.2018.07.008DOI Listing
December 2018

Report from the SWOG Radiation Oncology Committee: Research Objectives Workshop 2017.

Clin Cancer Res 2018 08 16;24(15):3500-3509. Epub 2018 Apr 16.

Department of Radiation Oncology, Columbia University Medical Center, New York, New York.

The Radiation Therapy Committee of SWOG periodically evaluates its strategic plan in an effort to maintain a current and relevant scientific focus, and to provide a standard platform for future development of protocol concepts. Participants in the 2017 Strategic Planning Workshop included leaders in cancer basic sciences, molecular theragnostics, pharmaceutical and technology industries, clinical trial design, oncology practice, and statistical analysis. The committee discussed high-priority research areas, such as optimization of combined modality therapy, radiation oncology-specific drug design, identification of molecular profiles predictive of radiation-induced local or distant tumor responses, and methods for normal tissue-specific mitigation of radiation toxicity. The following concepts emerged as dominant questions ready for national testing: (i) what is the role of radiotherapy in the treatment of oligometastatic, oligorecurrent, and oligoprogressive disease? (ii) How can combined modality therapy be used to enhance systemic and local response? (iii) Can we validate and optimize liquid biopsy and other biomarkers (such as novel imaging) to supplement current response criteria to guide therapy and clinical trial design endpoints? (iv) How can we overcome deficiencies of randomized survival endpoint trials in an era of increasing molecular stratification factors? And (v) how can we mitigate treatment-related side effects and maximize quality of life in cancer survivors? The committee concluded that many aspects of these questions are ready for clinical evaluation and example protocol concepts are provided that could improve rates of cancer cure and quality of survival. .
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http://dx.doi.org/10.1158/1078-0432.CCR-17-3202DOI Listing
August 2018

Update on International Cooperative Groups Studies in Thoracic Malignancies: The Emergence of Immunotherapy.

Clin Lung Cancer 2018 09 17;19(5):377-386. Epub 2018 Mar 17.

Division of Oncology, Department of Medicine, Stanford University, Stanford, CA. Electronic address:

Cancer cooperative groups have historically played a critical role in the advancement of non-small-cell lung cancer therapy. Representatives from cooperative groups worldwide convene at the International Lung Cancer Congress annually. The International Lung Cancer Congress had its 17th anniversary in the summer of 2016. The present review highlights the thoracic malignancy studies discussed by presenters. The included studies are merely a sample of the trials of thoracic malignancies ongoing globally.
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http://dx.doi.org/10.1016/j.cllc.2018.03.004DOI Listing
September 2018

Postoperative Chemoradiation in High-Risk Cutaneous Squamous Cell Carcinoma of the Head and Neck.

J Clin Oncol 2018 05 16;36(13):1269-1271. Epub 2018 Mar 16.

Aarti K. Bhatia, Barbara A. Burtness, and Roy H. Decker, Yale School of Medicine, Yale Cancer Center, New Haven, CT.

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http://dx.doi.org/10.1200/JCO.2018.77.7987DOI Listing
May 2018

Early Assessment of Lung Cancer Immunotherapy Response via Circulating Tumor DNA.

Clin Cancer Res 2018 04 12;24(8):1872-1880. Epub 2018 Jan 12.

Department of Therapeutic Radiology, Yale School of Medicine, Yale University, New Haven, Connecticut.

Decisions to continue or suspend therapy with immune checkpoint inhibitors are commonly guided by tumor dynamics seen on serial imaging. However, immunotherapy responses are uniquely challenging to interpret because tumors often shrink slowly or can appear transiently enlarged due to inflammation. We hypothesized that monitoring tumor cell death in real time by quantifying changes in circulating tumor DNA (ctDNA) levels could enable early assessment of immunotherapy efficacy. We compared longitudinal changes in ctDNA levels with changes in radiographic tumor size and with survival outcomes in 28 patients with metastatic non-small cell lung cancer (NSCLC) receiving immune checkpoint inhibitor therapy. CtDNA was quantified by determining the allele fraction of cancer-associated somatic mutations in plasma using a multigene next-generation sequencing assay. We defined a ctDNA response as a >50% decrease in mutant allele fraction from baseline, with a second confirmatory measurement. Strong agreement was observed between ctDNA response and radiographic response (Cohen's kappa, 0.753). Median time to initial response among patients who achieved responses in both categories was 24.5 days by ctDNA versus 72.5 days by imaging. Time on treatment was significantly longer for ctDNA responders versus nonresponders (median, 205.5 vs. 69 days; < 0.001). A ctDNA response was associated with superior progression-free survival [hazard ratio (HR), 0.29; 95% CI, 0.09-0.89; = 0.03], and superior overall survival (HR, 0.17; 95% CI, 0.05-0.62; = 0.007). A drop in ctDNA level is an early marker of therapeutic efficacy and predicts prolonged survival in patients treated with immune checkpoint inhibitors for NSCLC. .
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http://dx.doi.org/10.1158/1078-0432.CCR-17-1341DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5899677PMC
April 2018

Angiotensin receptor blockade: a novel approach for symptomatic radiation necrosis after stereotactic radiosurgery.

J Neurooncol 2018 Jan 9;136(2):289-298. Epub 2017 Nov 9.

Department of Therapeutic Radiology and Smilow Cancer Center, Yale School of Medicine, 333 Cedar Street, New Haven, CT, 06510, USA.

Preclinical evidence suggests angiotensin blockade therapy (ABT) decreases late radiation toxicities. This study aims to investigate the association between ABT and symptomatic radiation necrosis (SRN) following stereotactic radiosurgery (SRS). Resected brain metastases (rBM) and arteriovenous malformation (AVM) patients treated with SRS from 2002 to 2015 were identified. Patients in the ABT cohort were on therapy during SRS and at 1-month follow up. Kaplan Meier method and cumulative incidence model were used to analyze overall survival (OS) and intracranial outcomes. 228 consecutive patients were treated with SRS: 111 with rBM and 117 with AVM. Overall, 51 (22.4%) patients were in the ABT group: 32 (28.8%) in the rBM and 19 (16.2%) in AVM cohorts. Baseline characteristics were similar, except for higher Graded Prognostic Analysis (3-4) in the rBM (ABT: 25.0% vs. non-ABT: 49.0%, p = 0.033) and median age in the AVM (ABT: 51.4 vs. non-ABT: 35.4, p < 0.001) cohorts. In both populations, OS and intracranial efficacy (rBM-local control; AVM-obliteration rates) were statistically similar between the cohorts. ABT was associated with lower 1-year SRN rates in both populations: rBM, 3.1 versus 25.3% (p = 0.003); AVM, 6.7 vs. 14.6% (p = 0.063). On multivariate analysis, ABT was a significant predictive factor for rBM (HR: 0.17; 95% CI 0.03-0.88, p = 0.035), but did not reach statistical significance for AVM (HR: 0.36; 95% CI 0.09-1.52, p = 0.165). ABT use appears to be associated with a reduced risk of SRN following SRS, without detriment to OS or intracranial efficacy. A prospective trial to validate these findings is warranted.
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http://dx.doi.org/10.1007/s11060-017-2652-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5784434PMC
January 2018

Response.

J Natl Cancer Inst 2018 04;110(4):433-434

Department of Therapeutic Radiology, Yale University School of Medicine, New Haven, CT.

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http://dx.doi.org/10.1093/jnci/djx230DOI Listing
April 2018

Indications for invasive mediastinal staging in patients with early non-small cell lung cancer staged with PET-CT.

Lung Cancer 2017 07 25;109:36-41. Epub 2017 Apr 25.

Yale University School of Medicine, Department of Therapeutic Radiology, New Haven, CT, United States. Electronic address:

Purpose/objective(s): Appropriate use of invasive mediastinal staging in patients with clinically node-negative NSCLC staged by PET-CT is critical in selecting patients for curative-intent therapy such as surgery or SBRT, but little data exists to guide this decision-making. We examined a large population of patients with clinical stage I NSCLC referred for mediastinoscopy or EBUS to find risk factors for occult N2 lymph nodes and determine which patients benefit from invasive staging.

Materials/methods: We identified consecutive clinical T1-2N0 NSCLC patients being evaluated for curative-intent therapy between 2011 and 2015. None had evidence of nodal disease by PET-CT; the endpoint was pathologic confirmation of occult N2 disease by EBUS or mediastinoscopy. Tumor size, location, histology, SUV, and radiographic appearance were evaluated as determinants of occult N2 disease. Two group comparisons of continuous variables were done with independent t-tests and categorical variables were compared with χ or Fisher's exact test.

Results: In 284 patients with PET-CT-staged clinical T1-2N0 disease, the prevalence of occult N2 metastases was 7.0%. The negative predictive value of PET-CT was 92.9% and the negative predictive value of mediastinoscopy/EBUS was 96.3%. T2 tumors were more likely to have occult N2 disease than T1 tumors (11.8% v 3.6% p=0.009). Pure solid tumors had greater involvement of N2 nodes than tumors with any ground glass component (12.6% v 3.1%, p<0.001). 17.5% of central tumor cases were found to have occult N2 metastases while 4.4% of patients with peripheral tumors (P<0.001). 33.3% of patients with solid central T2 tumors had occult N2 metastases whereas 2.0% of patients with peripheral T2 tumors with a ground glass component, 1.2% of patients with peripheral T1 tumors with a ground glass component and 3.6% of patients with peripheral T1 solid tumors had N2 metastases.

Conclusions: Invasive mediastinal staging should be strongly encouraged in central tumors and solid T2 tumors because the risk of occult nodal involvement is greater than 10% in these cohorts. However, for patients with peripheral T1 tumors or peripheral T2 tumors with a significant ground glass component, the yield of invasive staging after a negative PET-CT is very low and invasive staging may not be warranted.
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http://dx.doi.org/10.1016/j.lungcan.2017.04.018DOI Listing
July 2017
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