Quality of life (QOL) in patients with esophageal cancer treated with radiation (RT) in the radical setting.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 186-186
Author(s):  
Anita Choudhary ◽  
Geoffrey Liu ◽  
Pravin Philip Chacko ◽  
Ehab Fadhel ◽  
Charles Cho ◽  
...  
Keyword(s):  
Esophageal Carcinoma ◽  
Statistical Significance ◽  
Disease Free Survival ◽  
Concurrent Chemotherapy ◽  
Shortness Of Breath ◽  
Curative Intent ◽  
Trimodality Therapy ◽  
Clinically Significant ◽  
One Year

186 Background: QOL is poorly documented in patients with esophageal carcinoma treated with curative intent, especially trimodality therapy. QOL and survival outcomes were evaluated in a single centre prospective cohort study of esophageal carcinoma patients treated with RT in the radical setting. Methods: Patients completed the EORTC-QLQC30 at baseline, the end of RT, 6 months and 1 year after RT. A 10-point difference in scores was considered clinically significant. Results: Thirty-three of 45 consequently treated patients between February 2012 and June 2014 participated, all male, median age 63 years (range 40-76), with T1-4N1-3M0 disease (AJCC 7thedn), median follow up 0.9 years (range 0.1-2.3). Four patients were treated definitively with chemoradiation 45-50Gy in 25 fractions; 14 neoadjuvantly 45-50Gy in 25 fractions; 15 neoadjuvantly 41.4Gy in 23 fractions, with concurrent chemotherapy. Compliance for questionnaire completion was 80-100%. 2 year overall survival (OS) and disease free survival (DFS) were 77% and 63%. Median scores on role, social, fatigue and appetite showed clinically significant worsening at the end of RT; in addition statistical significance was found for global QOL, physical, nausea/vomiting, and shortness of breath [median difference (MD): global -8.3 p=0.004, physical -6.6 p=0.003, role -16.6 p=0.001, social -16.6 p=0.78, nausea/vomiting 8.3 p=0.02, fatigue 22.2 p=0.001, shortness of breath 0 p=0.037, appetite 33.3 p=0.009]. At 6 months post RT global QOL (MD -16.6 p=0.23), physical (MD -13.3 p=0.007), role (MD -16.7 p=0.11) and fatigue (MD 11.1 p=0.18) were clinically significantly depressed. At one year all scores had returned to baseline, except pain, which was clinically significantly worse (MD 16.7 p=0.41); 64% of the cohort reported worse pain compared to baseline. Although global QOL on average returned to normal, 46% reported this to be clinically worse at one year compared to baseline. No association was found between baseline global QOL and OS (p=0.15) or DFS (p=0.57). Conclusions: QOL was worsened in several domains during and up to 6 months post RT. At one year all scores had returned to baseline except for pain which was significantly worsened in 64% of patients.

P125 HEALTH-RELATED QUALITY OF LIFE ONE YEAR AFTER THE DIAGNOSIS OF OESOPHAGEAL AND JUNCTIONAL CANCER: A POPULATION-BASED STUDY FROM THE SWEDISH NATIONAL REGISTRY FOR ESOPHAGEAL AND GASTRIC CANCER

2019 ◽  
Vol 32 (Supplement_2) ◽  
Author(s):  
Sunde Berit ◽  
Lindblad Mats ◽  
Malmström Marlene ◽  
Hedberg Jakob ◽  
Lagergren Pernilla ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Population Based ◽  
Health Related Quality ◽  
Definitive Chemoradiotherapy ◽  
Curative Intent ◽  
Palliative Intent ◽  
Related Quality ◽  
Health Related ◽  
One Year

Abstract Aim The aim of this study is to describe and analyse patient reported HRQoL one year after the diagnosis of oesophageal and junctional carcinoma in an unselected cohort comprising both palliative and curative intent patients. Background & Methods Short and long-term health-related quality of life (HRQoL) has been extensively described in operated oesophageal cancer patients in several population-based studies. However, the knowledge of HRQoL in patients with palliative intent management is not well described, and further, documentation of HRQoL in curative intent patients treated with definitive chemoradiotherapy is also quite scarce. A nation-wide population-based cohort, of patients diagnosed between 2009 and 2016 collected in the Swedish National Registry for Esophageal and Gastric Cancer (NREV) with prospectively registered exposure data and Health-related quality of life (HRQoL) outcome data. Validated instruments from the European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-OG25 were used, and data was analysed with means and adjusted mean differences. Results In patients alive one year after diagnosis, 1,156 responded to the HRQOL questionnaires and were included in the analyses. Both curative and palliative intent patients reported severe symptoms of problems in oesophageal specific domains. In the comparison between the curative and palliative intent groups, more prominent symptoms among palliative patients were detected regarding dysphagia (MD 11; 95% ci: 7-15) and anxiety (MD 10; 95% ci: 6 -15). Levels of anxiety were reported with high levels in all groups analysed and problems with dysphagia was also more common in patients treated with definitive chemoradiotherapy compared with surgically treated patients (MD 11; 95% ci: 4 -18) diagnosed in locally advanced disease stages. Conclusion One year after diagnosis high levels of anxiety were reported in all subgroups of oesophageal and junctional cancer patients, and problems with dysphagia are a major problem in the palliative intent subcohort and in patients treated with definitive chemoradiotherapy.

Survival and toxicity with intensity modulated radiation therapy (IMRT) and chemotherapy for esophageal carcinoma, with or without surgery.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 125-125
Author(s):  
Kristin Kowalchik ◽  
Elizabeth Johnson ◽  
George P. Kim ◽  
C. Daniel Smith ◽  
Siyong Kim ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Acute Toxicity ◽  
Esophageal Carcinoma ◽  
Locally Advanced ◽  
Late Toxicity ◽  
Concurrent Chemotherapy ◽  
Conformal Radiation Therapy ◽  
Trimodality Therapy ◽  
Grade 3 ◽  
3D Crt

125 Background: Treatment for locally advanced esophageal carcinoma is radiation and chemotherapy, with or without surgery. Radiation has traditionally been delivered with 3D conformal radiation therapy (3D CRT). This study evaluates late toxicity in patients treated with IMRT as well as early outcomes and acute toxicity. Methods: This is a retrospective review of 32 patients with esophageal carcinoma treated with IMRT at Mayo Clinic Florida from 2008 -2012. Pathology includes squamous cell and adenocarcinomas. Tumor sites include middle and lower thoracic and GE junction. Clinical stages are TX-T3, N0-3, M0-1. All patients received at least one cycle of concurrent chemotherapy. IMRT dose was 50.4 Gy in 28 fractions prescribed to a target volume including the tumor and regional lymphatics. IMRT plans utilized coplaner beams in a 7-9 beam arrangement or volumetric modulated arc therapy. Results: Median follow-up is 8.9 months (range 2.4-23.0) for all patients and 13.1 months (range 2.8-23.0 months) in surviving patients. Median patient age is 69 (range 46-87). Trimodality treatment was completed in 20 patients (62.5%). Surgery was either an open or minimally invasive esophagogastrectomy. The incidence of grade 3 or greater late toxicity at 1 year was 48% in surgery patients and 26% in non-surgery patients. The most common grade 3 or higher toxicity was esophageal strictures in 25%. The incidence of any grade 3 or greater acute toxicity was 65% in the surgery patients and 75% in the non-surgery patients. Overall survival (OS) for all patients at 18 months is 57% (CI 37-86%) and progression-free survival (PFS) is 60% (36-99%). OS and PFS for trimodality therapy at 12 months is 83% (66-100%) and 81% (63-100%) respectively and for bimodality therapy is 34% (12-93%) and 70% (33-100%) respectively. Conclusions: Increased late toxicity occurs in surgery patients, and increased acute toxicity in non-surgery patients. Lower survival in non-surgery patients may be due to early progression, morbidities which preclude surgery or improved survival with surgery. Overall, IMRT is a feasible treatment modality, which may be equally efficacious to 3D CRT for the treatment of esophageal carcinoma.

Yoga in women undergoing treatment for breast cancer: Impact on quality of life in a randomized controlled trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 527-527
Author(s):  
Nita S. Nair ◽  
Nishu Singh Goel ◽  
Rohini W Hawaldar ◽  
Shabina Siddique ◽  
Vani Parmar ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Adjuvant Therapy ◽  
Low Cost ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Disease Free Survival ◽  
Complementary Therapy ◽  
Significant Difference

527 Background: Yoga has been tested in multiple small-randomized studies for its impact on quality of life (QOL) on breast cancer (BC). We propose to study the effect of yoga on disease free survival as the primary endpoint in women with operable breast cancer. (Study methodology details refer to NCT02161900). Methods: Women with non-metastatic BC were randomized to yoga and conventional exercise (YCE) versus conventional exercise only (CE) in addition to standard therapy. Over and above documentation of recurrence and death, QOL was assessed in these women using the EORTC QLQC30, BR23, Brief fatigue inventory (BFI), Visual pain scores (VPS) and a spirituality questionnaire (SQ). EORTC QLQ was assessed at baseline (BL), 6-9 months (mo), 18-21 mo. BFI and VPS at BL, 6-8 mo and 12-15 mo and SQ at BL and 12-15 mo. We report the first interim analysis of QOL in 605 patients randomized to the study with atleast 1 year of follow up. The groups were balanced in both arms with respect to clinico-pathological factors. Results: At 6-9 mo (completion of adjuvant therapy), there was no significant difference in global QOL scores (p = 0.08), however 52% women on YCE showed an improvement from baseline compared to 42% in CE. At 18-21 mo emotional function scores were better in YCE (p = 0.002); with lesser systemic side effects in YCE arm (44% vs 56% p = NS). The median score of fatigue after adjuvant therapy measured by QLQ C30 was lower in YCE (17.37vs22.22, p = 0.003) which was similar to that observed by BFI at 12-15 mo (1.6vs 2, p = 0.04). Also in YCE there was lower reporting of detriment in general activity (41%vs 59%) and mood (34%vs66%) (p = NS). In VPS at 12-15mo, the median scores for pain intensity (p = 0.042), pain on movement (p = 0.038), pain on mobilization (p = 0.008) were lower in YCE. Lastly SQ assessed spirituality and showed no difference, but less deterioration compared to baseline scores in YCE. Conclusions: Yoga did not show a significant difference in global QOL but had a major benefit reaching statistical significance in fatigue, emotional score and pain. Yoga is a low-risk, low-cost complementary therapy that may improve compliance to therapy by improving parameters that can affect day-to-day activity in women with breast cancer. Clinical trial information: NCT02161900.

Comparison of bimodality versus trimodality therapy for esophageal or gastroesophageal junction (GEJ) cancer: Experience from the Princess Margaret Cancer Centre.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 122-122
Author(s):  
Akina Natori ◽  
Hao-Wen Sim ◽  
Bryan Anthony Chan ◽  
Peiran Sun ◽  
Stephanie Moignard ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Gastroesophageal Junction ◽  
Disease Free Survival ◽  
Cox Proportional Hazards ◽  
Curative Intent ◽  
Trimodality Therapy ◽  
Treatment Algorithms ◽  
Multivariable Regression ◽  
Cancer Experience

122 Background: There are no phase 3 trials comparing definitive chemoradiation (bimodality) versus. perioperative chemoradiation (trimodality) for locoregional esophageal/GEJ cancer. Methods: A retrospective analysis (2011-2015) compared bimodality and trimodality therapy in patients (pts) with locoregional esophageal/GEJ cancer treated with curative intent. Overall survival (OS) and disease-free survival (DFS) were calculated from the date of diagnosis. Uni- and multivariable Cox proportional hazards regression adjusted for patient and disease factors. Results: Of 108 patients, 82 (76%) were male. Mean ages were 69.5 ± 11.0 years (bimodality; N = 41) and 60.5 ± 11.1 years (trimodality; N = 67). For bimodality pts, 37% had adenocarcinoma and 63% had squamous cell carcinoma (SCC). For trimodality pts, 79% had adenocarcinoma and 21% had SCC (p < 0.0001). Bimodality pts received a higher radiation dose compared to trimodality pts (50.1 ± 6.7 vs. 45.2 ± 6.4 Gy). Median follow-up was 49.3 months. We found no significant OS difference between bimodality (27.0 months) and trimodality therapy (29.8 months) in the overall cohort (p = 0.57) (4 year OS rate: 42% vs. 38%). In the subgroup with adenocarcinoma histology, trimodality therapy significantly improved OS and DFS compared to bimodality (OS: 31.8 vs. 10.4 months, hazard ratio (HR) 0.34, 95% confidence interval (CI) 0.18-0.66, p = 0.001; DFS: 15.0 vs. 6.7 months; HR 0.39, 95%CI 0.21-0.73, p = 0.003). In the SCC subgroup, median OS and DFS were similar (OS: not reached vs. 29.2 months, p = 0.48; DFS: 27.0 vs. 24.0, p = 0.96). Using multivariable regression with AIC backward selection, the only retained prognostic factors were treatment modality (p = 0.06) and histology (p = 0.01). Conclusions: Our findings support preferential use of trimodality therapy for pts with adenocarcinoma histology given superior OS and DFS, whereas bimodality and trimodality therapy appeared comparable in pts with SCC histology. Pending confirmation in a larger series with longer follow-up, these findings suggest differential treatment algorithms for locoregional esophageal and GEJ cancer based on tumor histology.

scholarly journals Surgical Management of Malignant Pleural Mesothelioma: Impact of Surgery on Survival and Quality of Life—Relation to Chemotherapy, Radiotherapy, and Alternative Therapies

ISRN Surgery ◽  
2014 ◽  
Vol 2014 ◽  
pp. 1-13 ◽  
Author(s):  
Sotiris Papaspyros ◽  
Sayonara Papaspyros
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Malignant Pleural Mesothelioma ◽  
Disease Free Survival ◽  
Current Evidence ◽  
Perioperative Outcomes ◽  
Pleural Mesothelioma ◽  
Term Survival ◽  
Trimodality Therapy

Introduction. Malignant pleural mesothelioma (MPM) is an aggressive cancer arising from pleural mesothelium. Surgery aims to either cure the disease or control the symptoms. Two surgical procedures exist: extrapleural pneumonectomy (EPP) and pleurectomy/decortication (P/D). In this systematic review we assess current evidence on safety and efficacy of surgery. Methods. Five electronic databases were reviewed from January 1990 to January 2013. Studies were selected according to a predefined protocol. Primary endpoint was overall survival. Secondary endpoints included quality of life, disease-free survival, disease recurrence, morbidity, and length of hospital stay. Results. Sixteen studies were included. Median survival ranged from 8.1 to 32 months for P/D and from 6.9 to 46.9 months for EPP. Perioperative mortality was 0%–9.8% and 3.2%–12.5%, respectively. Perioperative morbidity was 5.9%–55% for P/D and 10%–82.6% for EPP. Average length of stay was 7 days for P/D and 9 days for EPP. Conclusion. Current evidence cannot definitively answer which procedure (EPP or P/D) is more beneficial in terms of survival and operative risks. This systematic review suggests that surgery in the context of trimodality therapy offers acceptable perioperative outcomes and long-term survival. Centres specialising in MPM management have better results.

Patient Safety Indicators for Judging Hospital Performance

2016 ◽  
Vol 32 (2) ◽  
pp. 129-133 ◽  
Author(s):  
John C. Kubasiak ◽  
Amanda B. Francescatti ◽  
Raj Behal ◽  
Jonathan A. Myers
Keyword(s):  
Patient Safety ◽  
False Positive ◽  
Disease Process ◽  
Hospital Performance ◽  
Patient Safety Indicators ◽  
Academic Center ◽  
Clinically Significant ◽  
Inherent Nature ◽  
One Year

Patient Safety Indicators (PSIs) were originally intended for use as a screen for quality of care but are now being used to rank hospitals and to modify hospital reimbursement. PSI data are dependent on accuracy of clinical documentation and coding. Information on whether a PSI event is inherent to the nature of the operation or posed a significant impact on the outcome is lacking. Cases for one year at a single academic center were queried. Cases with target PSIs were included (n = 136). Cases were evaluated for both the inherent nature and significance of injury. Both patient safety officers agreed that the PSI event was inherent to the disease process, and thus, the procedure and was not a marker of patient safety (false positive) in 11.8% to 33.3% of cases. Both reviewers agreed that the events were not clinically significant in 11.8% to 30.4% of cases. This study found high false-positive rates and only moderate interrater reliability for 3 PSIs. PSIs as currently reported are not reliable enough to be utilized for ranking.

Efficacy of intraoperative radiofrequency ablation (IRFA) combined or not with resection to treat unresectable colorectal metastases, with or without preoperative chemotherapy: The ARF2003 Study (NTC 00210106): Preliminary results

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4095-4095
Author(s):  
Y. Becouarn ◽  
S. Mathoulin-Pélissier ◽  
M. Rivoire ◽  
A. Ayav ◽  
J. Arnaud ◽  
...  
Keyword(s):  
Disease Free Survival ◽  
Median Number ◽  
Primary Objective ◽  
Colorectal Metastases ◽  
Stage Design ◽  
Preliminary Results ◽  
Secondary Endpoints ◽  
One Year

4095 Background: Only few patients suffering from colorectal metastases (CRM) can have surgery and thus hope for a 40% 5-year survival rate. Adding IRFA to resection may improve the efficacy of surgery. Methods: The primary objective was to evaluate the efficacy of IRFA combined or not with resection in terms of 3-month complete hepatic response (CHR) in patients with unresectable CRM. Secondary endpoints were overall survival (OS), disease-free survival (DFS), morbidity and quality of life. A phase II study based on a Simon's two-stage design was conducted in 6 university French hospitals. Number of subjects estimated was 53, with 19 for the 1st stage. At the end of the 1st stage, 12 CHR were required to continue recruiting. At the end of 2nd stage, 37 CHR would be required to claim efficacy. Results: Fifteen of the first 19 patients exhibited CHR allowing the study to pursue accrual which ended in Nov 08; some patients are still followed up. As of Nov 08, data had been collected on 47 patients (mean age 61 years): 6 had RFA alone (13%), 37 had RFA and resections (82%), 2 could not be treated (4%). Median number of CRM was 5 (1–12). All had chemotherapy pre-op and 12 post-op (29%). Three-month data were available for 36 patients: 1 patient died on the 3rd week following intervention. Scans were available for 35 patients (independently reviewed). Of these, 29 had CHR (83%); 13 had 3-month morbidity (37%). The median follow-up was 15 months. One-year OS and DFS rates were 92.3% and 26% respectively. Analysis on all 53 patients will be communicated in June 09. Conclusions: These preliminary results suggest that IRFA combined or not to resection may be efficient in treating unresectable diseases despite their more aggressive pattern. This corroborates the EORTCC CLOCC Trial findings which demonstrated IRFA superiority upon chemotherapy alone. IRFA could thus be valuably associated to resection in treating patients with colorectal metastases that resection alone could not handle. No significant financial relationships to disclose.

Triple-negative breast cancer (TNBC) outcomes with partial breast irradiation and concurrent chemotherapy (PBI-CC) compared with whole breast irradiation and sequential chemotherapy (WBI-SC).

2011 ◽  
Vol 29 (27_suppl) ◽  
pp. 115-115
Author(s):  
L. M. De Souza Lawrence ◽  
A. Shah ◽  
V. Stearns ◽  
F. Asrari ◽  
D. A. Frassica ◽  
...  
Keyword(s):  
Statistical Significance ◽  
Menopausal Status ◽  
Disease Free Survival ◽  
Distant Recurrence ◽  
Concurrent Chemotherapy ◽  
High Rate ◽  
Rank Test ◽  
Partial Breast Irradiation ◽  
Breast Irradiation ◽  
Significant Difference

115 Background: TNBC (ER/PR/HER2-negative) is associated with worse locoregional recurrence (LRR), disease-free survival (DFS), and overall survival (OS) than non-TNBC. MSKCC/Harvard recently reported a 5-yr local recurrence rate of 33% in TNBC patients treated with PBI (Pashtan et. al. ASTRO 2010). Having completed two prospective trials of PBI-CC, one previously reported (Zellars et al. JCO 2009), we reviewed the outcomes of TNBC patients treated with PBI-CC and compared them to those treated with WBI-SC. Methods: TNBC patients treated on 2 phase I/II PBI-CC protocols were compared to a cohort of TNBC patients treated at our institution with WBI-SC with respect to OS, DFS, LRR and in-breast tumor recurrence (IBTR). KM rates of local and distant recurrence, log-rank test of statistical significance are presented. Results: Between 2004 and 2009, 16 patients were treated with PBI-CC and 32 with WBI-SC. PBI-CC was 40.5 Gy (2.7 Gy x 15 QD) to the lumpectomy bed only with cycle 1 of ddAC (60/600 mg/m2 every 14 days with growth factor support x 4 cycles). WBI-SC patients received a med. dose (+ boost) of 60.7 Gy, (42.5 – 66), 5/32 had nodal irradiation. 28/32 recieved AC, and 4/32 C, Docetaxel. Med. follow-up is 38.4 mo (9.2–65.5) and 40.5 mo (5.6–77.8), respectively. There is no statistically significant difference between groups with respect to T/N stage, median age, and menopausal status. No patients died. All 6 recurrences (1 nodal, 4 IBTR, 1 distant) were in the WBI-SC group. Med. time to recurrence was 14.4 months (0.8–38.6). DFS at 3 yr/5 yr were 100% vs. 84.4% (p=0.10) and 100% vs. 81.3%. (p=0.07) in the PBI-CC and WBI-SC groups respectively. There is a trend towards decreased LRR (0% vs. 15.6%, p=0.12) and IBTR (0% vs. 12.5% , p=0.16), in favor of PBI-CC. Conclusions: Our results differ from earlier reports of a high rate of LRR in TNBC patients treated with PBI. This may be due to our use of concurrent chemotherapy with PBI or to undefined factors in our series of WBI-SC. Our data suggest improved DFS, LRR, and IBTR with PBI-CC when compared to retrospectively reviewed contemporary TNBC patients treated WBI-SC and should be externally confirmed.

Evaluation of sexual function on a randomized trial of a prostate rectal spacer.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 69-69 ◽  
Author(s):  
Daniel A. Hamstra ◽  
Dhiren Shah ◽  
Steven Kurtzman ◽  
John Sylvester ◽  
Shawn H. Zimberg ◽  
...  
Keyword(s):  
Sexual Function ◽  
Statistical Significance ◽  
Size Analysis ◽  
Patient Reported ◽  
High Prevalence ◽  
Spacer Arm ◽  
Clinically Significant ◽  
Penile Bulb

69 Background: The SpaceOAR phase 3 trial showed that a hydrogel spacer between the prostate and rectum decreased rectal dose and toxicity while improving bowel quality of life (QOL) after image guided prostate IMRT to 79.2 Gy. Here we evaluated dose to penile bulb as well as sexual function on this trial Methods: Sexual QOL was measured with the Expanded Prostate Cancer Index Composite (EPIC) by mean summary scores and the proportion of patients with a minimally important decline (MID) (11 points). Stratification was based on severe erectile dysfunction (ED)(EPIC < = 60) vs not. The single question on “Erections sufficient for intercourse over the preceding 4 weeks” was also evaluated. Results: Median Follow-up was 37 months with 63% of men evaluable at 3 years. With spacer the dose to the penile bulb was reduced for mean (21 vs 11 Gy), Dmax (46 vs 36 Gy), and V10-V30 (all p < 0.05). Baseline sexual function was 53 (±24) with 54% having severe ED with no difference between arms (p > 0.1). At 3 years average EPIC score was 39.7 (± 23) and 82% had severe ED with no differences between arms (p > 0.1). At enrollment 42% had EPIC > 60 with average summary of 77 (±8.3) which at 3 years was 53 (±24.8). In this sub-group at 3 years a higher EPIC was observed on the Spacer arm (57.7 (±24.1) vs. 44.6 (± 24.4)) which met the threshold for an MID without statistical significance (p = 0.07). Based on MID and twice that there was a trend favoring Spacer with 53% vs 75% for 11-point decline (p = 0.064) and 41% vs 60% for 22 point decline (p = 0.11). A small number of these men were potent at baseline and evaluable both at baseline and 3 years (n = 49). Of these 37.5% in the Control arm had erections sufficient for intercourse at 3 years as compared to 66.7% (p = 0.07) in the Spacer arm. Power analysis revealed 35% power to detect a change of 11 points between arms and 27% power to detect a difference of 22 points. Conclusions: The use of a hydrogel spacer decreased dose to the penile bulb with a suggestion of a clinically significant improvement in patient reported sexual function and potency. These did not achieve statistical significance potentially due to the high prevalence of ED at baseline and, therefore, the small evaluable sample size. Analysis of penile bulb dose and QOL is ongoing. Clinical trial information: NCT01538628.

Pertuzumab and trastuzumab as adjuvant treatment for HER2-positive early breast cancer: outcomes in Chinese patients in the APHINITY study

2021 ◽  
Vol 51 (3) ◽  
pp. 345-353
Author(s):  
Zhimin Shao ◽  
Ling-Ming Tseng ◽  
Chiun-Sheng Huang ◽  
Da Pang ◽  
Youngsen Yang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Breast Cancer ◽  
Adjuvant Treatment ◽  
Statistical Significance ◽  
Disease Free Survival ◽  
Chinese Patients ◽  
Primary Analysis ◽  
Her2 Positive ◽  
Curative Intent ◽  
Global Population

Abstract Background The addition of pertuzumab to trastuzumab plus standard chemotherapy as adjuvant therapy following surgery significantly improved invasive disease-free survival (IDFS) in patients with HER2-positive early breast cancer in the multinational randomized APHINITY trial (NCT01358877, BIG 4–11/BO25126/TOC4939G). We analyzed clinical outcomes in the subgroup of patients recruited at Chinese sites. Methods Patients were randomized to standard adjuvant chemotherapy plus 1 year of trastuzumab with pertuzumab or placebo. Patients recruited in mainland China, Hong Kong and Taiwan are included in this descriptive analysis. Results Chinese patients had similar demographic characteristics to the global population, but a higher proportion had nodal involvement. Although this subgroup analysis was not powered to detect statistical significance, a numerical improvement in IDFS was observed with the addition of pertuzumab to trastuzumab in Chinese patients (hazard ratio, 0.69; 95% confidence interval: 0.39–1.19; 3-year IDFS event-free estimates 92.5% [pertuzumab] and 91.7% [placebo]), which was consistent with the primary analysis of the global population. Further subgroup analyses showed numerical improvements in the Chinese node-positive, hormone receptor-negative and -positive subgroups, although confidence intervals were wide due to the low number of events. The incidence of diarrhea was higher in the pertuzumab arm, and no primary cardiac events occurred in Chinese patients in either arm. Conclusions Pertuzumab, used in combination with trastuzumab and chemotherapy in APHINITY, is effective as an adjuvant treatment regimen for Chinese patients with HER2-positive early breast cancer in a setting with curative intent. The safety profile in Chinese patients was consistent with that of the global population.

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