bluuebunny/crossref_metadata_2025_split huggingface dataset:
Long term follow up data of a phase II study of concurrent radiotherapy (RT) and gemcitabine (Gem) for patients with stage III or IV squamous cell carcinoma of the head and neck (SCCHN)
Authors: Specenier P. M. , Van Den Weyngaert D. , Van Laer C. , Van Den Brande J. , Huizing M. , Altintas S. , Vermorken J. 
Published: March 2020

5574 Background: RT with concurrent chemotherapy is superior to RT alone as treatment for locally advanced SCCHN. Gem is a potent radiosensitizer in vitro and in vivo and in addition has a good activity in SCCHN. Exploitation of these properties was the rationale for a single institution phase II study which evaluates the efficacy and toxicities of standard RT + weekly low dose Gem. Methods: Eligible were patients with primary inoperable or locally advanced stage III and IV SCCHN. Treatment: Planned RT was 70 Gy over 7 weeks with weekly Gem 100 mg/m2 within 2 hours prior to RT (Eisbrüch et al., ASCO, 1997, 1998). Presented endpoints are response rate (according to WHO), acute and late toxicity (according to NCICTC), disease free survival (DFS), local relapse free survival (LRFS) and overall survival (OS). Results: 26 patients (21 male, 5 female; performance status 0–2; no prior treatment) entered the study between November 1998 and September 2003. Median age was 56 years (range 48–78). Tumor sites were oropharynx (6), hypopharynx (17), glottis (1), paranasal sinus (1), unknown (1). Clinical stage was III (2) or IV (24). 7 Patients had T4N2 disease and 2 had T4N3 disease. Patients received a median of 7 Gem cycles (range 2–8) and a median of 70 Gy (66–84.75). 7 patients underwent radical neck dissection. Grade 3–4 acute toxicities included mucositis (22/26), dermatitis (18/26), pharyngitis and/or oesophagitis (21/26), pain (7/25), xerostomia (1/24), neutropenia (1/26) and anemia (1/26). 21/26 patients needed tube feeding and 21/26 needed to be hospitalized. After recovery from acute toxicity 6/23 could feed normally, 5/23 needed soft food, 5/23 were able to swallow liquid food and 2/23 required permanent tube feeding. Response was evaluable in 22 patients (11 CR, 11 PR). Intial relapse was at distant sites in 9/26 and local in 8/26. Median follow up of the patients still alive is 46 months. Median OS is 576 days, median DFS is 401 days, median LRFS is not reached. 7/26 remain free of disease more than 3 years after end of treatment. Conclusions: RT + Gem (100 mg/m2/week) is feasible but toxic. The combination is highly active in SCCHN and provides a good long term local control. [Table: see text]
Concurrent split course hyperfractionated radiotherapy (Hfx RT) with biweekly cisplatin (DDP) and paclitaxel (P) in patients with recurrent, previously irradiated squamous cell carcinoma of the head and neck (SCCHN): The MUSC experience
Authors: Sawhney R. , Dragun A. , Stuart R. K. , Chaudhary U. B. , Day T. , Gillespie M. B. , Sharma A. 
Published: March 2020

5578 Background: Locally recurrent disease (RD) contributes to the majority of SCCHN-related deaths. In addition, second primary tumors (SPT) develop in approximately 30% of patients (pts) who were cured of their primary malignancy. For pts with disease (RD or SPT) in a previously irradiated region, therapeutic options are limited. Approaches utilizing reirradiation with concurrent chemotherapy (CT) have been investigated, with promising initial results. We retrospectively report the clinical outcome & toxicity of such a regimen. Methods: A cohort of pts with locally recurrent or second primary SCCHN within previous radiation portals were treated with concurrent chemoradiotherapy (CRT). Pts received HFx RT (1.5 Gy/Fx BID × 5 every 2 wks × 4), in combination with DDP 15 mg/m2 IV QD × 5 and P 20 mg/m2 IV QD × 5 q 2 wks × 4. Filgrastim was given on days 6–13 of each 2 wk cycle. Results: Nineteen pts were treated (median age 61; 84% with RD at median of 22 mos, 16% SPT; primary site: oropharynx-32%, larynx-32%, oral cavity 21%). Two pts had treatment discontinued early (due to hemoptysis & declining performance status, respectively). Seventeen pts were evaluable at a median f/u of 13 mos. Acute skin & mucous membrane toxicity (Grade ≥ 2) was seen in 11% and 5% of pt’s, respectively, and 32% of pts developed skin fibrosis as a late radiation toxicity. Most pts (82%) received all 4 scheduled cycles of CT. Grade ≥ 3 hematologic toxicity occurred in 29% of pts (anemia 24%, neutropenia 24%, & thrombocytopenia 12%). Infection was the primary non-hematologic toxicity, with Grade ≥ 3 infection in 29% (4 pneumonia, 1 vascular catheter). There was 1 treatment-related death (hypotension with CVA). Of the 16 pts who completed treatment, 4 had initial surgery, and thus had no measurable disease upon commencing CRT. Objective responses to CRT were noted in all of the remaining 12 pts and 50% achieved a CR. One-year OS rate was 65%, with median survival not yet reached. Conclusions: RD and SPT pts who are not surgical candidates have limited treatment options. Aggressive reirradiation with biweekly CT produces excellent response rates, with acceptable local and systemic toxicities. No significant financial relationships to disclose.
Comparison of neoadjuvant 6 vs 8 cycles of docetaxel/doxorubicin/cyclophosphamide (TAC) in patients early responding to TACx2-the GEPARTRIO Study
Authors: Von Minckwitz G. , Blohmer J. , Vogel P. , Hanusch C. , Eidtmann H. , Hilfrich J. , Gerber B. , Huober J. , Costa S. , Kaufmann M. 
Published: March 2020

576 Background: Primary breast cancer (BC) patients (P) with early response to neoadjuvant TACx2 (75mg/m, 50 mg/m, 500 mg/m, day 1, q21, supported with (pegylated) G-CSF and epoetin) experience a high pathologic complete remission (pCR) rate after further TACx4 (von Minckwitz et al, Ann Oncol 2005) compared to patients without early response (SABCS 2005, Abst 38). We compared prolongation to 8 cycles of TAC with conventional 6 cycles TAC in the chemosensitive subgroup. Methods: P with operable (T 2 cm by palpation) or locally advanced (T4 or N3, M0) BC were treated with TACx2. If tumor reduction was exceeding 50% according to breast ultrasound, P were randomized to receive either 4 or 6 additional cycles. Endpoints were pCR-rate (no invasive and no non-invasive residuals) (primary), sonographic response before surgery, breast conservation rate, safety and compliance (secondary). To detect an increase in pCR-rate from 20 to 26%, 606 evaluable patients were requested for each arm (α=0.05, β=0.2, one-sided). Results: 2106 P were recruited into the multi-centre, prospective, open-label, randomized GEPARTRIO-trial within 36 months. 1400 P with an early response to TACx2 were randomized with the last patient having surgery in Dec 05. Median clinical tumor size was 4.0 (1.0 - 30.0) cm at study entry. A planned safety and blinded efficacy interim analysis was performed on the first 600 patients (306 TACx6, 294 TACx8). Main toxicities (grade I-IV %TACx6 vs %TACx8) were: anemia (91 vs 93), thrombopenia (39 vs 49), neutropenia (65 vs 75), febrile neutropenia (10 vs 16), infection (29 vs 30), vomiting (42 vs 44), diarrhea (59 vs 52), stomatitis (66 vs 67), conjunctivitis (51 vs 57), allergic reactions (20 vs 14), edema (40 vs 47), asthenia (90 vs 93), hand-foot-syndrome (25 vs 28), nail (43 vs 50), dyspnea (33 vs 37), sensory neuropathy (51 vs 61). Treatment was discontinued early in 165 P (31.0%), 53 (19.8%) P during TACx6 and 112 (42.3%) P during TACx8. Overall pCR was reported in 102 (17.0%) of these patients. Conclusions: TACx8 is associated with moderate increase in toxicity and treatment discontinuations compared to TACx6. Final results on the primary and secondary endpoints will be presented. [Table: see text]
Changes in circulating endothelial cells (CEL) in patients receiving trastuzumab for metastatic breast cancer predict response to treatment
Authors: Spadaro P. , Ingemi M. , Dottore G. , Toscano G. , Maisano R. 
Published: March 2020

579 Background: Amplification or overexpression of HER-2/neu has been identified in 10–20% of invasive breast cancers and is associated with shorter overall survival times; furthermore HER-2/neu is a predictive factor with regard to monoclonal antibody therapy with Trastuzumab. The observed association between the overexpression of HER-2/neu and higher VEGF expression indicates that HER-2/neu is involved, at least partly, in the regulation of angiogenesis in human breast cancer. Recently circulating endothelial cells (CECs) have been proposed as a marker of tumor progression and/or a response to antiangiogenic therapy; thus, we have performed a phase II study to explore the correlation between CECs and treatment with Trastuzumab in metastatic breast cancer Methods: 22 women aged ≥ 18 years with histologically proven Her-2-positive, ECOG performance status 0 to 2 who were not eligible for, or who wished to delay receiving chemotherapy received a standard loading dose of Trastuzumab 4 mg/Kg followed by 2 mg/Kg weekly. The weekly maintenance dose was continued until disease progression. A panel of monoclonal antibodies including anti CD45 to exclude hematopoietic cells, anti CD31, CD34, CD36, CD105, CD106, CD133, and KDR and appropriate analysis gates were used to enumerate resting and activated circulating endothelial cells Results: The overall response rate (RC + RP) to treatment was 25% (2 RC + 3RP). In healthy controls (N° 20) mean values of resting and activated CECs were 7.6/μL (4.6 - 11.2/μL) and 1.3/μL (0.1 - 2.4 /μL) respectively. Before treatment with Trastuzuamb the mean resting and activated CECs were 41.1/μL (16.4 - 60.5/μL) and 6.9/μL (5.1 - 8.7/μL). At a first assessment (6 wks) a significant decrease in CECs (p<0.001)was found in patients responding to treatment but not in the patients who did not achieve a remission Conclusions: Our finding has shown that resting and activated CECs are increased in metastatic breast cancer patients and decline during treatment in responding patients, furthermore, these data underline the crucial role of angiogenesis in this setting and support the rationale for a combination of Bevacizumab with Trastuzumab. No significant financial relationships to disclose.
Male breast cancer (MBC) in the VA population: A gender issue?
Authors: Nahleh Z. , Srikantiah R. , Komrokji R. , Safa M. , Pancoast J. , Muhleman A. , Jazieh A. 
Published: March 2020

587 Background: The incidence of MBC continues to rise. Few studies have addressed the differences between MBC and female breast cancer (FBC). Treatment for MBC has ben extrapolated from FBC regimens. The VA cancer registry (VACCR) provides a unique source to study MBC. This retrospective analysis aims at comparing the characteristics and outcome of MBC and FBC in the VA population. Methods: We reviewed the VACCR database between 1995 and 2005, for 120 VA medical centers. Primary breast cancer site codes were identified (500–508). Data was entered and analyzed using bio-statistical software SPSS. Results: A total of 3025 patients :612 MBC and 2413 FBC were compared. Mean age at diagnosis was 67 for MBC and 57 for FBC (p <0.005). More MBC patients were black. MBC patients presented with a significantly higher stage of disease, more node positive(N+) and larger tumor size. In MBC, ductal histology was more common while lobular and ductal carcinoma in situ were less common than in FBC. ER + and PR + tumors were significantly more common in MBC (60% vs 52% and 53% vs 47%, P< 0.005). MBC patients received less chemotherapy while no statistical difference in hormonal treatment was observed. The median overall survival (OS) was lower for MBC (7 years vs 9.8 years, p<0.005). OS was not significantly different for stage III and IV while OS was inferior for MBC in stage I (7 yr vs not reached, p 0.005) and stage II (6 vs 8.6yr, p 0.001). In N- tumors, OS was inferior in MBC (6.1 vs 14.6 yr, p<0.005) but not statistically different for N+ tumors . In ER + and PR + tumors, OS was inferior in MBC (7yr vs 8yr and 7.3 yr vs 9.8 yr p<0.005); however, no statistical significance was observed in ER - or PR - tumors. Using Cox regression analysis age, sex, clinical stage, nodal status were statistically independent prognostic factors while race, histology and grade were not. Conclusion: This study suggests differences in the biology, pathology, presentation, and survival between male and female VA breast cancer patients. Survival of MBC patients appears inferior in early stage disease and N- tumors suggesting gender differences in the tumor pathogenesis and biology. In hormone receptor + MBC, survival was also inferior despite similar hormonal treatment practices. This observational study calls for different approach and treatment strategies in MBC. No significant financial relationships to disclose.
Breast cancer treatment patterns of Asian-American women in an equal access system
Authors: Kang S. K. , Ely B. W. , Riffenburgh R. H. , Chung T. S. , Chan A. D. , Hu J. S. 
Published: March 2020

589 Background: Treatment patterns of breast cancer in Asian-American women have not been well studied. Existing studies suggest higher mastectomy rates compared to Whites, but have been unable to control for differences in access to healthcare. The objective was to describe primary and adjuvant treatment patterns of Asian women in an equal-access healthcare system. Methods: Data were extracted from the tumor registry to include women diagnosed with T1-T2, M0 breast cancer between 1989 and 2004 and treated at the Naval Medical Center San Diego, an equal-access system. Self-reported data was used to classify race. Military rank was used as a proxy for socioeconomic status and education level. Characteristics and treatment patterns of Asian and White women were compared by the two-sided Fisher’s exact test and multiple logistic regression with consideration of covariates. Results: 574 non-Hispanic White and 226 Asian-American women resulted from the query. Asian women received mastectomy more often than Whites. From 1989 to 2004, mastectomy rates declined for both groups at an equal rate until 1997. On secondary analysis based on the initial results, differences in mastectomy rates existed only until 1997, which was coincident with the opening of a multidisciplinary Breast Health Center. Asians were much less likely to receive breast reconstruction. There was no difference in rates of adjuvant radiation or chemotherapy, but a suggestion of higher hormone therapy rates in Asians. Conclusions: Even in the setting of an equal-access healthcare system, Asian-American women were more likely to receive mastectomy than Whites, suggesting that barriers to healthcare access do not explain these treatment disparities. This difference disappeared in recent years. The contrasting reconstruction rates suggest a difference in cultural attitudes regarding the significance of the breast in the setting of cancer treatment. The multidisciplinary Breast Health Center may have ameliorated factors leading to higher mastectomy rates in Asians. [Table: see text] No significant financial relationships to disclose.
A randomized controlled trial (RCT) of long-term follow-up for early stage breast cancer comparing family physician to specialist care: A report of secondary outcomes
Authors: Grunfeld E. , Julian J. , Levine M. , Pritchard K. , Coyle D. , Dent S. , Verma S. , Mirsky D. , Sawka C. , Ginsburg D. , Wood M. 
Published: March 2020

6003 Background: Breast cancer patients usually receive follow-up in specialist cancer clinics. We have reported that family physician follow-up of breast cancer patients is a safe and acceptable alternative to specialist follow-up as measured by the primary clinical outcome of the rate of serious clinical events (Grunfeld et al, JCO 2006;24(6)). We report here the secondary outcomes of this trial: quality of life domains, patient satisfaction and patients’ costs. Methods: Women with early stage breast cancer who had completed adjuvant therapy (patients may have continued on adjuvant hormonal therapy), who were disease free and between 9 and 15 months after diagnosis, were allocated to receive follow-up in a cancer clinic according to usual practice (CC arm) or follow-up from their own family physician (FP arm). For patients without recurrence, quality of life (QL) measured by the SF36, patient satisfaction, and patients’ costs were measured every 6 months. For patients with recurrence QL measured by the EORTC QLQ C-30 was measured at the time of recurrence. Results: 483 patients were allocated to the FP arm and 485 to the CC arm. Median follow-up was 3.5 years. There were no significant differences between groups on change scores for SF36 subscales to 24 months, or EORTC functional subscale scores at the time of recurrence. Patients’ costs of follow-up (travel costs, out-of-pocket expenses, and lost earnings) were significantly less to 24 months (p < 0.02) in the FP arm. Although costs were less between 36 and 48 months, these were not significant. Conclusions: Family physician follow-up of breast cancer patients does not have a negative impact on clinical or QL outcomes and is less costly for patients. No significant financial relationships to disclose.
Impact of a mass media campaign (MMC) on awareness of and willingness to participate in cancer clinical trials (CCT): Results from 2,269 survey respondents
Authors: Umutyan A. , Lara P. N. , Chiechi C. , Turrell C. , Chen M. S. , Paterniti D. A. , Wun T. , Davis S. , Gonzalez J. , Beckett L. A. 
Published: March 2020

6012 Background: Annually, only 3% of patients (pt) participate in CCT. Accrual barriers include lack of CCT awareness and uncertain third party coverage. In 1/02, a California law (SB37) required all third party payers to reimburse pt care costs related to CCT. We sought to increase awareness of CCT/SB37 through a MMC, and assessed willingness to participate. Methods: Following a pre-MMC survey of 1,188 cancer pt and/or their caregivers’ awareness and willingness levels (JCO 2005; 23:9282–89), a TV/radio/print/internet MMC was conducted in a 9-county catchment area for UC Davis Cancer Center from 4/05–6/05. The MMC emphasized CCT/SB37 availability and used an iconic “Big C” logo. The survey was repeated post-MMC in two pt/caregiver cohorts: from the UC Davis Cancer Center catchment area (C1), and a control group from the UC San Diego area (C2) who did not see the MMC. Changes in CCT/SB37 awareness and willingness to participate were probed pre- vs. post-MMC and C1 vs. C2 by Pearson χ2 & logistic regression. Results: Of 2,269 respondents, 1,081 were post-MMC: 957 from C1 and 124 from C2. Post-MMC respondents differed from pre-MMC by respondent type (pt > caregivers), age (older), race (more blacks), and income (more $75k+/yr). Pre- vs. post-MMC, C1 respondents had greater awareness of CCT (59% to 65%, p < 0.01) and SB37 (17% vs. 32%, p < 0.01); no significant change was seen in C2. Adjustment for demographic variables in C1 resulted in p > 0.05 for CCT/SB37 awareness. Willingness to participate in CCT did not change pre- vs. post-MMC in C1 or C2. Awareness level predicted willingness (OR = 2.3, p < 0.01), but this was not true for the lowest income/education groups. Blacks/Asians/lowest income (< $25K/yr) groups were least willing to participate (p < 0.01/0.04/0.02). Conclusions: Although CCT/SB37 awareness increased in C1 following the MMC, it is unclear whether this was wholly attributable to the MMC due to varying demographic variables. Awareness of CCT/SB37 did not universally translate into willingness to participate in all subgroups. Enhancing pt willingness (to increase CCT accrual) will require targeting other variables, such as physician or resource barriers, rather than just CCT/SB37 awareness. (R21 CA-03501). No significant financial relationships to disclose.
Diagnostic assessment of suspected cancer: Prospective cohort study of diagnostic delay intervals across three disease sites
Authors: Watters J. , Grunfeld E. , Jaffey J. , O’Rourke K. , Maziak D. , Patel D. , Morash C. , Evans W. K. 
Published: March 2020

6029 Background: Diagnostic assessment of patients with suspected cancer can involve multiple points of delay. Methods: We conducted a cohort study of prospective eligible patients referred to a regional hospital in Ottawa, Ontario, Canada over a 12 month period (2004 to 2005) for diagnostic assessment of suspected colorectal (C), lung (L) or prostate (P) cancer. The study addressed three different disease sites, each with a different pre-existing model of care delivery, so that variability could be described. Measurement of diagnostic delay intervals included days to diagnosis (from referral to diagnosis communicated to the patient) and, for patients with cancer, to surgery and to oncology consultation. Differences between disease sites for diagnostic delay intervals, quality of life, and patient satisfaction were analyzed. Results: The proportion of patients who were diagnosed with cancer was: 6.8% (9/132) for C; 80.2% (81/101) for L; and 35% (41/116) for P. The mean [SD] days to diagnosis was significantly less for L (45 [32]) than for either C (81 [68]) for P (82 [43]), (p=.0001). It was also significantly less for patents diagnosed with cancer (57.8)[41.4]) than for those without cancer (79.3)[58.9]) (difference -21.5; 95% CI -33 to -9; p=.0003); a finding which held when C was analyzed separately (33.8 [48.9] vs 84.8 [67.7]; p=.04). L patients had worse physical and mental functioning as measured by the SF36 Physical and Mental Component Scores. Patient satisfaction did not differ across disease site or for patients with and without cancer. Conclusions: Most studies of diagnostic delay intervals use administrative data. This study is unique in prospectively measuring intervals that cannot be captured from administrative data and thus provides important benchmark measures. L patients were most likely to have cancer. Although C patients were unlikely to have cancer, the diagnostic interval was substantially shorter in those with cancer than in those without, suggesting that clinicians have an effective process for triaging patients referred for diagnostic assessment. No significant financial relationships to disclose.