Neoadjuvant chemotherapy (NACT) followed by interval debulking surgery versus upfront surgery followed by chemotherapy (CT) in advanced epithelial ovarian carcinoma (EOC): A prospective randomized study—Interim results

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 5531-5531 ◽  
Author(s):  
L. Kumar Prof ◽  
R. Hariprasad ◽  
S. Kumar ◽  
N. Bhatla ◽  
S. Thulkar ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Neoadjuvant Chemotherapy ◽  
Blood Loss ◽  
Postoperative Morbidity ◽  
Disease Free Survival ◽  
Debulking Surgery ◽  
Free Survival ◽  
The Impact ◽  
Disease Free

5531 Background: To determine the impact of NACT on surgical debulking rate, overall and disease-free survival and quality of life (QOL) in patients with advanced EOC. Methods: Between Oct 2001 and Dec 2006, 128 previously untreated EOC patients (median age- 50 years, range 30 to 65) with FIGO stage III C & IV (pleural effusion only) have been randomized into - Arm A (n=65) upfront debulking Surgery followed by 6 cycles of Paclitaxel & carboplatin (PC) and Arm B (n=63): NACT with 3 cycles of PC followed by debulking Surgery then 3 more cycles. Eligibility criteria include - age 18 to 65 years, biopsy / cytological proven EOC, adequate hematological, renal, liver & cardiac functions, normal upper & lower GI endoscopy & CEA levels. Both groups were compared for debulking rate, duration of surgery, blood loss, intra & postoperative morbidity & mortality, overall response to treatment and QOL (FACT- O questionnaire). Results: 100 of 128 patients have completed treatment (arm A- 56, B-44). 7 patients were not evaluable; (Germ cell tumor-1, mixed Mullerian tumor-2, dual primary-1 and krukenburg-3). 93 patients are evaluable. Patients’ characteristics are similar in both arms. Grade III-IV - GIT (3% vs. 4%) & bone marrow (9% Vs 7%, p=ns) toxicity was similar in arm A & B, among 463 CT cycles administered. Patients in NACT arm had higher optimum debulking rate, p<. 0001, decreased blood loss during surgery (mean vol 520 vs 373 ml p<0.003) and reduced postoperative infections 14.8 % vs. 2.5%, p<0.04. Mean operative time (110 vs 95 minutes, p=0.12) and hospital stay (12 Vs 9.4 days, p=0.1) were similar in arm A & B. The median overall survival (arm A & B: 42 vs 29 months, p=0.07) and disease free survival (20 vs 25 months, p=0.11) is not different at a median follow up of 41 months. QOL score was significantly better in NACT arm at the end of treatment. (93 vs 114, p<. 001). Conclusions: Neoadjuvant chemotherapy in advanced epithelial ovarian cancer is associated with higher optimum debulking rate with reduced postoperative morbidity and improved quality of life. No significant financial relationships to disclose.

scholarly journals 306. Role of adjunct Ayurvedic treatment in increasing disease free survival and improving quality of life in cancer patients

2018 ◽  
Vol 9 (2) ◽  
pp. S13
Author(s):  
Shrinivas Datar ◽  
Swapna Kulkarni ◽  
Nilambari Patil ◽  
Amruta Salunkhe ◽  
Suchita Vaidya ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cancer Patients ◽  
Disease Free Survival ◽  
Free Survival ◽  
Ayurvedic Treatment ◽  
Disease Free

Patient Preferences for Adjuvant Interferon Alfa-2b Treatment

2001 ◽  
Vol 19 (3) ◽  
pp. 812-823 ◽  
Author(s):  
Kerry L. Kilbridge ◽  
Jane C. Weeks ◽  
Arthur J. Sober ◽  
Frank G. Haluska ◽  
Craig L. Slingluff ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Disease Free Survival ◽  
Interferon Alfa ◽  
Health States ◽  
Free Survival ◽  
Risk Melanoma ◽  
Melanoma Patients ◽  
Disease Free ◽  
Adjuvant Interferon

PURPOSE: Although trials of adjuvant interferon alfa-2b (IFNα-2b) in high-risk melanoma patients suggest improvement in disease-free survival, it is unclear whether treatment offers improvement in overall survival. Widespread use of adjuvant IFNα-2b has been tempered by its significant toxicity. To quantify the trade-offs between IFNα-2b toxicity and survival, we assessed patient utilities for health states associated with IFN therapy. Utilities are measures of preference for a particular health state on a scale of 0 (death) to 1 (perfect health).PATIENTS AND METHODS: We assessed utilities for health states associated with adjuvant IFN among 107 low-risk melanoma patients using the standard gamble technique. Health states described four IFNα-2b toxicity scenarios and the following three posttreatment outcomes: disease-free health and melanoma recurrence (with or without IFNα-2b) leading to cancer death. We also asked patients the improvement in 5-year disease-free survival they would require to tolerate IFN.RESULTS: Utilities for melanoma recurrence with or without IFNα-2b were significantly lower than utilities for all IFNα-2b toxicities but were not significantly different from each other. At least half of the patients were willing to tolerate mild-moderate and severe IFNα-2b toxicity for 4% and 10% improvements, respectively, in 5-year disease-free survival.CONCLUSION: On average, patients rate quality of life with melanoma recurrence much lower than even severe IFNα-2b toxicity. These results suggest that recurrence-free survival is highly valued by patients. The utilities measured in our study can be applied directly to quality-of-life determinations in clinical trials of adjuvant IFNα-2b to measure the net benefit of therapy.

scholarly journals Time to Surgery Does Not Influence Survival Outcome in Patients With Upfront Resected Pancreatic Adenocarcinoma

2021 ◽  
Author(s):  
Mathias Brugel ◽  
Olivier Bouché ◽  
Reza Kianmanesh ◽  
Lugdivine Teuma ◽  
Ahmad Tashkandi ◽  
...  
Keyword(s):  
Pancreatic Adenocarcinoma ◽  
Postoperative Morbidity ◽  
Disease Free Survival ◽  
Delay Group ◽  
Specialist Care ◽  
Postoperative Complication Rate ◽  
Free Survival ◽  
Time To Surgery ◽  
The Impact ◽  
Disease Free

Abstract BackgroundThis study evaluated the impact of time to surgery (TTS) on overall survival (OS), disease free survival (DFS) and postoperative complication rate in patients with upfront resected pancreatic adenocarcinoma (PA).MethodsWe retrospectively included patients who underwent upfront surgery for PA between January 1, 2004 and December 31, 2014 from four French centers. TTS was defined as the number of days between the date of the first consultation in specialist care and the date of surgery. DFS for a 14-day TTS was the primary endpoint. We also analyzed survival depending on different delay cut-offs (7, 14, 28, 60 and 75 days).ResultsA total of 168 patients were included. 59 patients (35%) underwent an upfront surgery within 14 days. Patients in the higher delay group had significantly more vein resections and endoscopic biliary drainage. Adjusted OS (p = 0.44), DFS (p = 0.99), fistulas (p = 0.41), hemorrhage (p = 0.59) and severe post-operative complications (p = 0.82) were similar in both groups. Other delay cut-offs had no impact on OS or DFS.DiscussionTTS seems to have no impact on OS, DFS and 90-day postoperative morbidity.

scholarly journals The Quality of Cervical Cancer Brachytherapy Implantation and the Impact on Local Recurrence and Disease-Free Survival in Radiation Therapy Oncology Group Prospective Trials 0116 and 0128

2012 ◽  
Vol 22 (1) ◽  
pp. 123-131 ◽  
Author(s):  
Akila N. Viswanathan ◽  
Jennifer Moughan ◽  
William Small ◽  
Charles Levenback ◽  
Revathy Iyer ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Radiation Therapy ◽  
Radiation Therapy Oncology Group ◽  
Disease Free Survival ◽  
Oncology Group ◽  
Free Survival ◽  
Prospective Trials ◽  
The Impact ◽  
Disease Free

PurposeThe objective of the study was to determine the impact of brachytherapy implant quality on outcome among cervical cancer patients treated on Radiation Therapy Oncology Group prospective trials 0116 and 0128.MethodsAll enrolled patients received concurrent chemoradiation followed by brachytherapy. Individual brachytherapy parameters, including the symmetry of ovoids in relation to the tandem, displacement of ovoids in relation to the cervical os, tandem bisecting the ovoids, tandem in the midpelvis, and appropriateness of packing, were scored for each implant. Multivariate Cox proportional hazards models were constructed for each parameter for local recurrence (LR), regional recurrence, distant recurrence, disease-free survival (DFS), and overall survival.ResultsRecords for 103 patients were analyzed. The median follow-up time was 24.5 months. Patients with unacceptable symmetry of ovoids to the tandem had a significantly higher risk of LR than patients in the acceptable group (hazard ratio [HR], 2.67; 95% confidence interval [CI], 1.11–6.45;P= 0.03). Patients with displacement of ovoids in relation to the cervical os had a significantly increased risk of LR (HR, 2.50; 95% CI, 1.05–5.93;P= 0.04) and a lower DFS rate (HR, 2.28; 95% CI, 1.18–4.41;P= 0.01). Inappropriate placement of packing resulted in a lower DFS rate (HR, 2.06; 95% CI, 1.08–3.92;P= 0.03).ConclusionsAssessment of the quality of a brachytherapy implant is imperative, as proper placement has an impact on patient DFS. If feasible, inappropriate placements should be corrected before treatment initiation. Brachytherapy applicators for cervical cancer should preferably be placed and assessed by experienced practitioners.

scholarly journals Effect of Traditional Chinese Medicine Collaborative Model (TCMCM) combined Adjuvant Chemotherapy in IIIb and IIIc Gastric Cancer: Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
zhaoyan li ◽  
Jia Li ◽  
Nida Cao ◽  
Xiaohong Zhu ◽  
Yan Xu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Gastric Cancer ◽  
Clinical Trial ◽  
Adjuvant Chemotherapy ◽  
Disease Free Survival ◽  
Stage Iiib ◽  
Free Survival ◽  
Auricular Acupressure ◽  
Disease Free

Abstract BackgroundMetastasis and/or recurrence are the primary cause in decreasing the survival time of gastric cancer patients who experienced radical operation. Among whom, patients with stage IIIb and IIIc are especially in high risk of metastasis and recurrence, result in a significant poor survival time than patients with earlier stages. Herbal medicines are natural substances that have been used for centuries in China, auricular acupressure and acupoints has shown promise in reducing side effects of chemotherapy，this traditional Chinese medicine collaborative model（TCMCM）has been studied in cancer, however, the specific effects have not been systematically evaluated. This study was designed to evaluate whether TCMCM can decrease adverse effects after chemotherapy and reduce the recurrence rate and metastasis in stage IIIb and IIIc gastric cancer. Method/designThis prospective，multicenter, randomized, open-label trail will recruit 260 patients with stage IIIb and IIIc gastric cancer who undergo radical surgery with D2 lymphadenectomy. Randomization to usual adjuvant chemotherapy or the intervention (TCMCM) with a 1:1 ratio will be used. Patients in the intervention group received an oral traditional Chinese formula, auricular acupressure and acupoints, all participants will be continuing to receive usual adjuvant chemotherapy. The primary outcome is 3-year disease free survival rate. Secondary outcomes include quality of life，side effects caused by chemotherapy and safety outcome measures. Assessments will be performed at Screening period and 4，8 cycles after adjuvant chemotherapy，9, 12, 18, 24,30 and 36 months after randomization, and adverse events will be recorded.In addition,biological samples will be collected for mechanism exploration studies. DiscussionThis will be the first clinical trial to evaluate the disease-free survival (DFS) and improvements in quality of life in patients of stage IIIb and IIIc gastric cancer receiving TCMCM, which may be used to formulate a standardized TCMCM plan. We are also performing this trial to assess the feasibility of a larger-scale clinical trial in the future. Trail registrationClinicalTrials.gov，NCT03607656. Registered on 1 July 2018.The final protocol version was V1.1.

Efficacy, Toxicity, and Quality of Life in Older Women With Early-Stage Breast Cancer Treated With Letrozole or Placebo After 5 Years of Tamoxifen: NCIC CTG Intergroup Trial MA.17

2008 ◽  
Vol 26 (12) ◽  
pp. 1956-1964 ◽  
Author(s):  
Hyman B. Muss ◽  
Dongsheng Tu ◽  
James N. Ingle ◽  
Silvana Martino ◽  
Nicholas J. Robert ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Older Women ◽  
Short Form ◽  
Age Groups ◽  
Disease Free Survival ◽  
Life Questionnaire ◽  
Free Survival ◽  
Disease Free

Purpose National Cancer Institute of Canada Clinical Trials Group trial MA.17 randomly assigned 5,187 postmenopausal, hormone-receptor–positive patients with early breast cancer who completed 5 years of tamoxifen to receive either letrozole or placebo. At 30 months median follow-up, letrozole significantly improved disease-free survival (DFS) in all patients and overall survival (OS) in node-positive patients. Breast cancer incidence increases with age and more than 1,300 women age 70 years or older were enrolled onto MA.17, making it ideal to explore the benefits, toxicities, and quality of life (QOL) impact of letrozole on older women. Patients and Methods In this study, 5,169 randomly assigned patients were divided into three age groups: younger than 60 years (n = 2,152), 60 to 69 years (n = 1,694), and ≥ 70 years (n = 1,323). Log-rank test was used to compare differences in DFS, distant-disease–free survival, and OS between age and treatment groups, and Cox models were used to estimate hazard ratios and associated 95% CIs. QOL was measured using the Medical Outcomes Short Form-36 and the Menopause-Specific Quality-of-Life questionnaire. Results At 4 years, DFS demonstrated statistically significant differences favoring letrozole only in patients age younger than 60 years (hazard ratio = 0.46; P = .0004); there was no interaction between age and treatment, indicating a similar effect of letrozole among all age groups. There was no difference in toxicity or QOL at 24 months among letrozole- and placebo-treated patients age ≥ 70 years. Conclusion Healthy patients age 70 years and older completing 5 years of tamoxifen should be considered for extended adjuvant therapy with letrozole.

scholarly journals 3-month versus 6-month adjuvant chemotherapy for patients with high-risk stage II and III colorectal cancer: 3-year follow-up of the SCOT non-inferiority RCT

2019 ◽  
Vol 23 (64) ◽  
pp. 1-88 ◽  
Author(s):  
Timothy Iveson ◽  
Kathleen A Boyd ◽  
Rachel S Kerr ◽  
Jose Robles-Zurita ◽  
Mark P Saunders ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Treatment Group ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Disease Free Survival ◽  
Free Survival ◽  
Disease Free

Background Oxaliplatin and fluoropyrimidine chemotherapy administered over 6 months is the standard adjuvant regimen for patients with high-risk stage II or III colorectal cancer. However, the regimen is associated with cumulative toxicity, characterised by chronic and often irreversible neuropathy. Objectives To assess the efficacy of 3-month versus 6-month adjuvant chemotherapy for colorectal cancer and to compare the toxicity, health-related quality of life and cost-effectiveness of the durations. Design An international, randomised, open-label, non-inferiority, Phase III, parallel-group trial. Setting A total of 244 oncology clinics from six countries: UK (England, Scotland, Wales and Northern Ireland), Denmark, Spain, Sweden, Australia and New Zealand. Participants Adults aged ≥ 18 years who had undergone curative resection for high-risk stage II or III adenocarcinoma of the colon or rectum. Interventions The adjuvant treatment regimen was either oxaliplatin and 5-fluorouracil or oxaliplatin and capecitabine, randomised to be administered over 3 or 6 months. Main outcome measures The primary outcome was disease-free survival. Overall survival, adverse events, neuropathy and health-related quality of life were also assessed. The main cost categories were chemotherapy treatment and hospitalisation. Cost-effectiveness was assessed through incremental cost comparisons and quality-adjusted life-year gains between the options and was reported as net monetary benefit using a willingness-to-pay threshold of £30,000 per quality-adjusted life-year per patient. Results Recruitment is closed. In total, 6088 patients were randomised (3044 per group) between 27 March 2008 and 29 November 2013, with 6065 included in the intention-to-treat analyses (3-month analysis, n = 3035; 6-month analysis, n = 3030). Follow-up for the primary analysis is complete. The 3-year disease-free survival rate in the 3-month treatment group was 76.7% (standard error 0.8%) and in the 6-month treatment group was 77.1% (standard error 0.8%), equating to a hazard ratio of 1.006 (95% confidence interval 0.909 to 1.114; p-value for non-inferiority = 0.012), confirming non-inferiority for 3-month adjuvant chemotherapy. Frequent adverse events (alopecia, anaemia, anorexia, diarrhoea, fatigue, hand–foot syndrome, mucositis, sensory neuropathy, neutropenia, pain, rash, altered taste, thrombocytopenia and watery eye) showed a significant increase in grade with 6-month duration; the greatest difference was for sensory neuropathy (grade ≥ 3 was 4% for 3-month vs.16% for 6-month duration), for which a higher rate of neuropathy was seen for the 6-month treatment group from month 4 to ≥ 5 years (p < 0.001). Quality-of-life scores were better in the 3-month treatment group over months 4–6. A cost-effectiveness analysis showed 3-month treatment to cost £4881 less over the 8-year analysis period, with an incremental net monetary benefit of £7246 per patient. Conclusions The study achieved its primary end point, showing that 3-month oxaliplatin-containing adjuvant chemotherapy is non-inferior to 6 months of the same regimen; 3-month treatment showed a better safety profile and cost less. For future work, further follow-up will refine long-term estimates of the duration effect on disease-free survival and overall survival. The health economic analysis will be updated to include long-term extrapolation for subgroups. We expect these analyses to be available in 2019–20. The Short Course Oncology Therapy (SCOT) study translational samples may allow the identification of patients who would benefit from longer treatment based on the molecular characteristics of their disease. Trial registration Current Controlled Trials ISRCTN59757862 and EudraCT 2007-003957-10. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 64. See the NIHR Journals Library website for further project information. This research was supported by the Medical Research Council (transferred to NIHR Evaluation, Trials and Studies Coordinating Centre – Efficacy and Mechanism Evaluation; grant reference G0601705), the Swedish Cancer Society and Cancer Research UK Core Clinical Trials Unit Funding (funding reference C6716/A9894).

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