bluuebunny/crossref_metadata_2025_split huggingface dataset:
The incidence and impact of comorbidity on survival and selection of initial treatment in elderly patients (pts) with head and neck cancer (HNC)
Authors: Ghobadi A. , Athar M. , Dowell J. 
Published: August 2020

6065 Background: Comorbidity has been shown to be a determinant of survival and treatment selection in various cancers including HNC. Higher comorbidity index is associated with higher utilization of non-curative intent treatment. Methods: In this retrospective study we analyzed 182 consecutively treated HNC pts >65 years (y) old at the Dallas VAMC from January 2000 through June 2007. Comorbidity was assessed with the Charlson Comorbidity Index (CCI). Treatment was classified as curative intent versus non-curative intent. The goals were 1) to demonstrate burden of comorbidity and 2) to demonstrate the impact of comorbidity on overall survival and selection of initial treatment in elderly HNC pts. Results: Pts characteristics: 100% male; 80% white, 19.5% Black, 0.5% Hispanic; median age 72y (range 65–87); 3% stage 0, 26% stage I, 20% stage II, 18% stage III, 30% stage IV, 2% unknown; primary site - 30% oral cavity, 4% hypopharnyx, 22% oropharynx, 38% larynx, 4% other, 1% unknown; treatment - 26% radiation only, 44% surgery (S), 21% chemoradiation (CR), 9% no treatment; Median CCI -2 (range 0–11); 61% had CCI score 0–2 and 39% had CI score > 3. Median overall survival was 883 days (SE 19.31 days). Rate of curative vs. non-curative intent treatment was 80% vs. 20% respectively. Pts with CCI score 0–2 had a non-significant higher rate of curative intent treatment than pts with CCI score > 3 (83.8% vs. 74.6% p = 0.13). In multivariate analysis including CCI, age, race, alcohol use, primary site, treatment, and stage, only advanced clinical stage had significant prognostic importance (HR 1.66; 95% CI, 1.29 to 2.14; p < 0.0005). The HR for CCI was 1.11 (95% CI, .99–1.24; p = 0.08). In separate multivariate analyses of pts treated with S and pts treated with CR, CCI was not a significant predictor of survival with HR of .88 (95% CI, .69–1.11; p = 0.29) and 1.13 (95% CI, .83–1.53; p = 0.44), respectively. Conclusions: In our population of elderly HNC pts, CCI and age had no significant impact on survival or selection of curative intent treatment. Additional study is required to better define appropriate candidates for curative intent treatment in this population. No significant financial relationships to disclose.
Longitudinal oncology registry of head and neck carcinoma (LORHAN): First report of outcomes
Authors: Curran W. J. , Chen A. Y. , Garden A. S. , Harari P. , Murphy B. A. , Wong S. , Bellm L. A. , Schwartz M. , Dawson D. , Ang K. K. 
Published: August 2020

6071 Background: Registries can be invaluable for describing patterns of care and outcomes for a population of patients (pts). We report the initial survival findings from LORHAN, a prospective, longitudinal, observational national registry of head and neck carcinoma (HNC) pts. Methods: Pts are eligible for LORHAN if they have newly diagnosed HNC, are scheduled to receive radiotherapy (RT) or drug therapy, are ≥18 years of age and have provided written informed consent. Data are entered in the registry electronically and transferred via Secure HTTP protocols. Patient confidentiality is strictly maintained. Pts are followed from time of initial diagnosis and for a minimum of 2 and up to 10 years. When information is complete and has been verified and signed off by the investigator, a record is locked. Only locked records are summarized and reported. Results: 2,354 pts have been enrolled in LORHAN since Dec. 2005. Of these, 1,326 pts have completed initial cancer treatment and have locked records. 1- and 2-year follow-up data are available for 583 and 56 pts, respectively. Baseline characteristics were similar between settings, except that pts treated at academic centers were significantly younger (58 vs. 62 years of age), had poorer performance status (mean Zubrod: 0.9 vs. 0.7), had fewer laryngeal tumors (17% vs. 27% of pts) but more oropharyngeal tumors (42% vs. 37% of pts) and presented with more advanced disease (stage IV: 70% vs. 48% of pts) compared to pts treated in community. Treatment did not differ by setting. Treatment and survival data are shown below. Conclusions: LORHAN demonstrates it is feasible to collect more detailed information about patient and tumor features and treatment other than surgery. Changes in the pattern of care and survival findings are expected to emerge as newer regimens, including IC and targeted agents, are incorporated more broadly into clinical practice, and data in LORHAN matures. [Table: see text] [Table: see text]
Reporting of endpoints and tracking of failures in randomized trials of radiotherapy or concurrent chemoradiotherapy for locally advanced head and neck squamous cell cancer (LA-HNSCC)
Authors: Le Tourneau C. , Michiels S. , Gan H. , Siu L. 
Published: August 2020

6072 Background: Due to their anatomical complexity, the interactive effects of multiple treatment modalities, the difficulties in differentiating scar tissues versus residual disease and second cancers versus tumor recurrence, LA-HNSCC represent a challenging disease for the reporting of endpoints and the tracking of failures. Methods: We retrieved all randomized trials that began accrual on or after 1978, and enrolled previously untreated nonmetastatic HNSCC patients receiving primary (chemo)radiotherapy. The reporting of endpoints and the tracking of failures in these trials were analyzed. Failures were defined as events meeting a pre-specified endpoint definition. Results: Forty trials involving 13,892 patients fulfilled our inclusion criteria. A total of 125 endpoints were identified: primary versus secondary = 34:91, survival-based (e.g., overall survival [OS]) versus surrogate (e.g. locoregional control [LRC]) = 47:78. In 6 trials, no primary endpoint was identified. LRC and OS accounted for 70% of primary endpoints. All but one trial reported at least one secondary endpoint, with a median of 2 per trial (range: 0–5), and as many as 17 different types of secondary endpoints were reported. Among 72 endpoints tracking locoregional failures, 21/72 (29%) did not define locoregional failure, while 46/72 (64%) specified the absence of complete response as a failure. Whether salvage surgery or elective node dissection was performed or not was reported in less than half of the trials. Furthermore, it was usually not specified if residual disease found during these procedures would account for failure or not. The means (i.e. clinical and/or radiological examinations) to ascertain failures and the protocol-specified timing to track failures were reported in 41% and 67% of surrogate endpoints, respectively. The tracking of other types of failure beyond the first failure is not reported by any of the trials. The reporting of second cancers was found in 15/40 (38%) trials, whereas the duration of follow-up was quantified in 31/40 (78%) trials. Conclusions: These results demonstrate the vast heterogeneity in endpoint reporting and tracking of failures in clinical trials of LA-HNSCC. No significant financial relationships to disclose.
Association between human papillomavirus (HPV) status with serum cytokine and angiogenic factor (CAF) profile after induction chemotherapy in head and neck squamous cell carcinoma (HNSCC)
Authors: Byers L. A. , Heymach J. V. , Lee J. J. , Lin H. , El-Naggar A. K. , Papadimitrakopoulou V. , Lippman S. M. , Hong W. K. , Holsinger F. C. , Kies M. S. 
Published: August 2020

6081 Background: Human papillomavirus has been implicated in the development of head and neck squamous cell carcinoma and is associated with a more favorable clinical outcome. Previously, we identified a serum hypoxia signature associated with HNSCC progression (Byers et al, Proc ASCO. 2008). We investigated the association between HPV status, serum biomarkers, and clinical outcome in patients treated with induction chemotherapy. Methods: 47 previously untreated patients with locally advanced nodal disease (T0–4, N2b/c/3, M0) received 6 weekly cycles of paclitaxel (135 mg/m2), carboplatin (AUC 2), and cetuximab (400 mg/m2 week 1; 250 mg/m2 weeks 2–6) followed by definitive local therapy. 46 (98%) patients had a complete or partial response to induction chemotherapy (Kies et al, Proc ASCO. 2006), and 6 have had tumor progression (PD) after a minimum follow-up of two years. Formalin fixed biopsies were available for HPV testing by in situ hybridization with non-radioisotopic chromogen for 25 patients (including 5/6 with PD). 38 CAFs were measured by multiplex bead assay before and during treatment. Results: 12/25 patients were HPV-positive, all male and six were never smokers; of the 13 HPV-negative patients, four were male and three were never smokers. Among those with available data, all 5 patients with PD were HPV-negative (p = 0.02). There were four study deaths, all in the HPV-negative group. Overall survival was superior in HPV-positive patients (p = 0.04). There was no significant association between HPV status and serum CAF markers. However, among HPV-negative patients, PD was associated with the CAF hypoxia signature (5/8 patients with the hypoxia signature progressed versus 0/5 signature-negative). Of the individual CAFs, osteopontin was significantly elevated in all HPV-negative patients with PD. Conclusions: HPV positivity was associated with a longer progression-free survival and overall survival. Among HPV-negative patients, only those with a serum hypoxia signature had disease progression. These data suggest that the combination of HPV status and CAF profiling may identify patients at risk for relapse after sequential therapy. No significant financial relationships to disclose.
The clinical impact and outcomes of immunohistochemistry-only metastases in breast cancer
Authors: Pugliese M. S. , Stempel M. M. , Patil S. M. , Hsu M. , Cody H. S. , Morrow M. , Gemignani M. L. 
Published: August 2020

613 Background: Modern surgical and pathologic techniques can detect small volume axillary metastases in breast cancer. The clinical significance of these metastases was evaluated in comparison to patients with negative sentinel lymph nodes (Neg-SN). Methods: Retrospective database review from 1997 through 2003 for eligible patients with unilateral breast cancer and no history of significant non-breast malignancy identified 232 patients with sentinel lymph node (SLN) metastases identified only by immunohistochemical stains (IHC-SN). They were compared to 252 Neg-SN controls selected at random from the same database population. Statistical analysis was performed with 2-sample tests, Kaplan-Meier, and Cox regression methods. Results: IHC-SN patients had worse prognostic features and received more systemic therapy than controls (Table). Age and ER status were similar. In 123 IHC-SN patients treated with axillary dissection (ALND), 16% had macrometastases in the non-SLNs. Only one axillary recurrence occurred in the group of IHC-SN patients without ANLD (n=109). With median follow up of 5 years (range 0.01–12.0), 28 recurrences and 25 deaths occurred. There were no differences between cases and controls for recurrence-free survival (RFS) or overall survival (OS) both by univariate and multivariate models that included variables such as age, tumor size, chemotherapy and hormone therapy [HR 0.99 (95%CI 0.43–2.28, p=0.99) for RFS, HR 2.06 (95%CI 0.79–5.35) p=0.14 for OS]. In IHC-SN patients treated with ALND, patients with positive non-SLNs (n=20) tended to have worse RFS than those with negative non-SLNs (n=103) [RFS 89% vs. 97% at 5 yrs (p=0.06)]. Conclusions: A significant number of IHC-SN patients had a macrometastasis identified at ALND. In patients not undergoing dissection, axillary recurrence was a rare event. However, failure to identify additional metastases by omitting ALND may result in understaging and inadequate systemic treatment in some patients. [Table: see text] No significant financial relationships to disclose.
Determinants of therapeutic delays and their impact on axillary node involvement in operable invasive breast cancer (BC) patients (pts)
Authors: Dionysopoulos D. , Berrada N. , Chevalier J. , Rimareix F. , Mathieu M. , Balleyguier C. , Gouy S. , André F. , Vielh P. , Delaloge S. , Delaloge S. 
Published: August 2020

615 Background: International guidelines recommend rapid diagnostic and therapeutic procedures for suspect breast lesions. However, the impact of the interval between screening and treatment (trt) (STI) on the severity of the disease remains unclear. We explored the potential impact of STI on a surrogate of survival, axillary nodal involvement (N+), among 1,000 recently diagnosed BC pts, as well as the causes of potential delays. Methods: We collected complete data of prospectively recorded community BC cases in a single regional cancer center between January 1, 2005, and October 10, 2007. Pts were eligible if they i. had a final diagnosis of invasive BC ii. were operated as first trt for BC, iii. had no history of other previous malignancy within the past 5 year period. Logistic regression analyses (SAS) were used to determine factors predictive of N+ and those influencing intervals between first description of the lesion and first therapeutic surgery (STI). Candidate factors included socio-economic variables (marital status, occupation, county of living, country of birth), personal and familial medical history parameters, as well as BC characteristics. Results: 990 pts met the inclusion criteria and had full data available. Med age: 59 years, BI-RAD ACR3/4/5: 2/41/55%, med pathological tumor size (pT): 16 mm (2–100), N+: 41%, med delay between first description of the lesion and surgery: 67 days. Factors predicting longer STI were: Birad ACR<5 vs 5 (p = 0.0004), not palpable lesion vs palpable (p = 0.01), microcalcifications vs solid lesion (p = 0.0008), presence of important comorbidities (p=.04), single life vs couple (p = 0.001). However, STI had no effect on N+: med STI was 68 days in N- vs 66 days in N+ pts. Factors predictive of N+ were lymphovascular invasion (LVI) (p=.0001) and pT (p = 0.0001), while age, social conditions, screening mode, per-cutaneous biopsy vs FNAC, grade, HR and HER-2 status, had no effect. Among pts with grade III BC, LVI (p = 0.0001) and pT (p = 0.02) were the sole predictors of N+ as well. Conclusions: This study identifies for the first time factors able to negatively influence STI of women with invasive BC. However, longer STI does not appear to influence axillary nodal invasion, even in pts with high grade BC. No significant financial relationships to disclose.
Sentinel and axillary nodes of the breast distinguished from those of the arm by 3D-CT lymphography and selectively dissected by endoscopic surgery
Authors: Yamashita K. , Haga S. , Shimizu K. 
Published: August 2020

616 Background: In early breast cancer, the presence of metastasis in axillary lymph nodes (AN) is an important factor in prognosis and further treatment. However, AN dissection causes many complications such as contracture of shoulder joint, lymph edema, and paralysis of upper extremities. Sentinel node (SN) biopsy provides us valuable information about no need to dissect AN for node-negative patients. However, on node-positive patients, the conventional AN dissection has been performed. 3D-CT lymphography (LG) can show the precise individual lymphatic flow not only from the breast tumor to SN but also from SN to venous angle, which means breast lymphatic channel. We applied 3D-CT LG to distinguish them from the arm channel to avoid any arm complications. Methods: 3D-CT LG was performed on the day before surgery to mark SN on the skin. Above the tumor and near the areola and the arm pit, 2 ml of Iopamidol 300 was injected subcutaneously. Images of 16-channel multidetector-row helical CT scan were taken at 1, 3, and 5 min after injection. They were reconstructed to produce a 3D image of lymph ducts and lymph nodes. SN biopsy and AN sampling were performed by dye-staining method using endoscopy. Results:We performed SN biopsy with 3D-CT LG on 160 patients. 3D-CT LG clearly showed the precise lymphatic flow from the tumor to SN. It can show SN at only one min after injection. But following up to 5 min, we can follow the lymph ducts beyond SN into the second to the fifth node groups toward the venous angle with complex plexus, observed in the surrounding anatomical architecture. Detection rate was 100% for SN; 80% for the third group; and 30% for the fifth group. The arm lymph flow was distinguished by the connections between the breast and the arm flow, observed 39% and 71% in the fourth and the fifth group. SN was shared from between the breast and the arm in 5 patients (3.1%). They complained arm edema only by SN biopsy. We can distinguish and sample AN drained from the breast, guided by 3D-CT LG and dye-staining using endoscopy. Conclusions:By 3D-CT LG, we can recognize the accurate and more precise lymph flow in the surrounding anatomical architecture. It helps us easily to pursuit lymph flow and to remove SN and AN from the breast selectively using endoscopic surgery. No significant financial relationships to disclose.
Surgical practice patterns following NCCTG N0338 “Phase II trial of docetaxel and darboplatin administered every two weeks as induction therapy for stage II and stage III breast cancer.”
Authors: Apsey H. , Roy V. , Pockaj B. , Northfelt D. , Sticca R. , Nikcevich D. A. , Mattar B. , Fitch T. , Perez E. A. 
Published: August 2020

623 Background: Neoadjuvant therapy plays an important role in breast cancer treatment. Unlike patients who undergo surgery followed by adjuvant therapy,there are no established guidelines for surgical management following neoadjuvant therapy. Methods: Surgical practice patterns from 50 patients in N0338 “Phase II trial of Docetaxel and Carboplatin administered every two weeks as induction therapy for Stage II and Stage III breast cancer” were reviewed. The protocol did not mandate surgical therapy leaving the decision to the treating surgeon and patient. Results: 66% of patients underwent mastectomy (M) and 33% underwent breast conservation therapy (BCT). Three (9%) had immediate reconstruction. Eight (24%) underwent contralateral prophylactic M. Residual tumor size did not always impact primary surgical therapy. In the M group 4 (12%) had no residual disease, 15 (45%) < 2cm and 14 (42%) > 2cm; whereas, in the BCT group 1 (6%) had no residual disease, 12 (70%) < 2cm and 4 (24%) > 2cm. Axillary lymph node (ALN) staging varied tremendously. Three (6%) patients presented with palpable lymphadenopathy and proceeded to complete axillary lymph node dissection (ALND) after chemotherapy (CT). Fine needle aspiration (8) or core needle biopsy (7) of the axilla was performed in 15 (30%) patients before CT; 1 was negative and went on to have sentinel lymph node biopsy (SLNB) after CT; 14 (94%) were positive with 13 (86%) going on to ALND and 1 SLNB after CT. Five (10%) underwent SLNB prior to CT. One (20%) was positive and went on to have ALND after CT; 4 (8%) were negative and had no further ALN staging. A total of 19 (39%) had SLNB after neoadjuvant therapy; 13 (68%) were positive and underwent ALND; 1 SLNB failed; 2 of 5 that were negative underwent ALND with 1 having a positive lymph node. Ten (20%) underwent ALND with no pre-operative staging with 8 being positive for ALN metastases. Conclusions: Review of study data from multiple institutions revealed no consistent criteria in selection of surgical intervention for the breast tumor or ALN staging. There remains a need for further research in this area to establish standard practice guidelines. Support from NIH, sanofi-aventis, Amgen, Breast Cancer Research Foundation. No significant financial relationships to disclose.
A novel approach for sentinel lymph node identification using fluorescence imaging and image overlay navigation surgery in patients with breast cancer
Authors: Tagaya N. , Abe A. , Tachibana M. , Kubota K. 
Published: August 2020

624 Background: We reported a novel technique of sentinel lymph node (SLN) identification using fluorescence imaging of indocyanine green injection. Furthermore, to obtain safe and accurate identification of SLN during surgery, we introduce the image overlay navigation surgery and evaluate its efficacy. Methods: This study enrolled 30 patients with a tumor less than 3 cm in diameter. Initially we obtained three-dimensional (3-D) imaging from MD-CT by volume rendering of Osirix (Macintosh, Apple Inc.). It was projected on the patient’ operative field with the clear visualization of LN through the micro projector (Mpro 110, Sumitomo 3M). And then the dye of indocyanine green was injected subdermally in the areola. Subcutaneous lymphatic channels draining from the areola to the axilla were visible by fluorescence imagings (Photodynamic eye: PDE, Hamamatsu Photonics Co.) immediately. Lymphatic flow was reached after LN revealed on 3-D imaging. After incising the axillary skin on the point of LN mapping, SLN was then dissected under the guidance of fluorescence and 3-D imaging with adequate adjustment of sensitivity. Results: Lymphatic channels and SLN were successfully identified by PDE in all patients. And the sites of skin incision were also identical with the LN being demonstrated by 3-D imaging in all patients. The mean number of SLN was 2.8. The adjustment of sensitivity of PDE provide with the reduction of operation time. The image overlay navigation surgery was visually easy to identify the location of SLN from the axillary skin. There were no intra- or postoperative complications associated with SLN identification. Conclusions: This combined navigations of fluorescence and 3-D imagings revealed more easy and effective to detect SLN intraoperatively than fluorescence imaging alone. The operator's demand was satisfied with the introduction of image overlay navigation surgery consisted of augmented reality and mixed reality, and it may be practical in the various surgical fields. No significant financial relationships to disclose.