Broad safety impact of high-dose ascorbic acid and induction chemotherapy for high-risk pancreatic cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15711-e15711
Author(s):  
Howard Bruckner ◽  
Azriel Hirschfeld ◽  
Daniel Gurell ◽  
King Lee
Keyword(s):  
Quality Of Life ◽  
Weight Loss ◽  
Ascorbic Acid ◽  
High Risk ◽  
Stage Iv ◽  
High Dose ◽  
Cost Treatment

e15711 Background: High dose ascorbic acid inhibits many tumors in vitro. It may reduce chemotherapy's adverse hematologic events and improve quality of life. Moderate dose gemcitabine, fluorouracil, leucovorin, irinotecan, oxaliplatin (GFLIP) is an effective regimen for patients with many cancers (Anticancer Research 17). High dose ascorbic acid may reverse half the preexisting and largely eliminate the predicted cumulative toxicity of GFLIP (ASCO 15). Methods: High dose ascorbic acid AA 75-100 grams IV was given 1-2 times per week with GFLIP every 2 weeks until progression with serial wkly and Q2wk blood tests and 3 month imaging. Eligibility: Unresectable, III, recurrent and metastatic, mod and high grade typical pancreatic ca; ECOG 0-2; +/- prior chemo; adults of any age with consent. Results: A prescheduled 2 yr analysis found 26 patients; 16 ≥ 65, (9 ≥ 70 years of age). 25 stage IV; Nine had failed at least one prior standard chemo (35%), 3 were PS 2, 9 had severe weight loss. Safety: Five had uncomplicated 3 (19%) and none had 4 neutropenia or neutropenic infection, one (4%) had a 3 anemia and thrombocytopenia without bleeding. Prophylactic growth factors were not used and limited to 1-2 as needed low doses used infrequently. There was no limiting diarrhea, enteritis, stomatitis, weight loss or coagulopathy due to GFLIP. GFLIP is on track to reproduce/retain prior response and survival benefit (ASCO 08). Conclusions: Ascorbic Acid-GFLIP can be exceptionally safe and well tolerated. It may avoid standard 20-40% rates of severe toxicities. It can be, otherwise unavailable, safe reduced cost, treatment for many elderly and prior resistant tumor patients. Given the broad multi-disease role of the GFLIP drugs, and available personalized medicine tests (Cancer Letters), further development is very attractive and feasible. Potential outcome can spare all, and especially high risk pancreatic ca patients, 20k severe toxicities every year toxicities as much as $100 million cost and make some ineligibility criteria unnecessary. Development of safe AA regimens may benefit quality of life and improve survival for many with a broad spectrum of cancers that otherwise go untreated. Clinical trial information: NCT01905150.

Nutritional intervention in high-risk patients receiving radiation for a broad spectrum of tumor types.

2017 ◽  
Vol 35 (8_suppl) ◽  
pp. 203-203 ◽  
Author(s):  
Chelsea Hertel ◽  
Amir Harandi ◽  
Cliff P. Connery ◽  
Dimitrios Papadopoulos ◽  
Keyword(s):  
Quality Of Life ◽  
Weight Loss ◽  
Radiation Therapy ◽  
High Risk ◽  
Nursing Staff ◽  
Nutritional Intervention ◽  
High Risk Patients ◽  
Risk Patients ◽  
Tumor Types

203 Background: Malnutrition is very common in patients receiving radiation therapy. This can result in significant weight loss, decreased functioning, depression, increased mortality, and dramatic declines in quality of life during and after treatment. Targeting patients at risk with nutritional counseling and progressive intervention can have important clinical implications. Methods: A total of 106 patients at a hospital-based cancer center getting radiation for a wide spectrum of cancers (breast, lung, gastrointestinal, genitourinary, and other types) were evaluated for individualized nutritional counseling and education. Patients with identified risk factors were deemed to be at high risk by nursing staff if meeting pre-specified criteria for weight loss ( > 2.5%), body mass index < 18.5%, and/or gastrointestinal symptoms (poor appetite, diarrhea, or constipation affecting quality of life). After high risk patients were identified by a nursing staff triage questionnaire, an automatic computer generated referral was made to the nutritionist. Results: Prior to the institution of this protocol, 13.7% of patients getting radiation therapy were noted to be at high risk and not receiving any nutritional intervention during their course of radiotherapy. However, after the initiation of adequate screening by nursing staff triggering a nutrition referral, the percentage of high risk patients without an associated nutrition consult declined to 1.1%. Conclusions: This study conveys important information for having a systemic screening process in place to identify those at risk for progressive malnutrition while getting radiotherapy for a broad spectrum of tumor types.

scholarly journals Role of high dose octreotide LAR for the treatment of GEP-NETs

2009 ◽  
Vol 3 (1) ◽  
pp. 7-14
Author(s):  
Giulia M. Franchi ◽  
Chiara Cappelletti ◽  
Valentina V. Villa ◽  
Emanuele Bosi ◽  
Marco F. Manzoni
Keyword(s):  
Quality Of Life ◽  
Tumour Growth ◽  
Neuroendocrine Tumours ◽  
Clinical Symptoms ◽  
Standard Dose ◽  
Diagnostic Tools ◽  
High Dose ◽  
Octreotide Lar

Neuroendocrine Tumours (NETs) are a heterogeneous group of rare neoplasms that account for 0,5% of all malignancies. The increased incidence observed in the last few decades may be accounted for by increased awareness, improved diagnostic tools and a revision in the definition. The main primary sites are the gastro-entero-pancreatic (GEP) tract (62-67%), and the lung (22-27%). In patients with GEP-NETs, the strongest predictor of 5-years survival is the staging. An adequate clinical management of GEP-NETs should be multidisciplinary and should aim at assuring a good quality of life. Somatostatin (sst) analogues are widely used in these tumours, which often express sst receptors, since they are demonstrated to reduce clinical symptoms and tumour growth. Herein we explore the usefulness of doubling octreotide LAR dose in selected patients after escaping from symptoms control and/or tumour stabilization in course of treatment with standard dose.

Quality-of-Life–Adjusted Survival Analysis of High-Dose Adjuvant Interferon Alfa-2b for High-Risk Melanoma Patients Using Intergroup Clinical Trial Data

2002 ◽  
Vol 20 (5) ◽  
pp. 1311-1318 ◽  
Author(s):  
Kerry L. Kilbridge ◽  
Bernard F. Cole ◽  
John M. Kirkwood ◽  
Frank G. Haluska ◽  
Michael A. Atkins ◽  
...  
Keyword(s):  
Quality Of Life ◽  
High Risk ◽  
Interferon Alfa ◽  
Trial Data ◽  
Phase Iii ◽  
High Dose ◽  
High Risk Melanoma ◽  
Risk Melanoma ◽  
Adjuvant Interferon

PURPOSE: High-dose adjuvant interferon alfa-2b (IFNα2b) for high-risk melanoma is a 1-year regimen that improves relapse-free and overall survival but has significant toxicity. A quality-of-life–adjusted survival (QAS) analysis analysis of two cooperative group phase III trials, E1684 and E1690/S9111/C9190, was performed, incorporating patient values (utilities) for the toxicity of IFNα2b treatment and melanoma recurrence. PATIENTS AND METHODS: Quality-Adjusted Time Without Symptoms or Toxicity methodology was used with melanoma patient utilities and trial data to estimate the effect of IFNα2b on QAS. The increase or decrease in QAS that patients could expect from treatment was estimated based on their utilities. Eleven utility predictor questions were tested to identify patients with utilities that result in decreased QAS. RESULTS: Using E1684 data, IFNα2b would result in an increase in QAS for all sets of patient utilities. This benefit was significant (P < .05) for 16% of patients. Using E1690/S9111/C9190 data, 77% of patients would experience a benefit in QAS from IFNα2b and 23% would experience a decrease in QAS; neither of these effects was statistically significant. Using utility predictors and the E1690/S9111/C9190 analysis, a decision rule was formulated that helps identify patients in whom IFNα2b may detract from QAS. CONCLUSION: Most patients experienced improvement in QAS in both trials, but this benefit was statistically significant in only 16% of patients in E1684. Change in QAS depends more on the utility for IFNα2b toxicity than on the utility for melanoma recurrence. Cancer patients probably have higher utilities for IFNα2b toxicity than members of the general population and will tend to favor IFNα2b treatment as a result.

scholarly journals Gastrointestinal symptoms and weight loss in cancer patients receiving chemotherapy

2012 ◽  
Vol 109 (5) ◽  
pp. 894-897 ◽  
Author(s):  
Karla Sánchez-Lara ◽  
Emilio Ugalde-Morales ◽  
Daniel Motola-Kuba ◽  
Dan Green
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Weight Loss ◽  
High Risk ◽  
Cancer Patients ◽  
Gastrointestinal Symptoms ◽  
Tumour Site ◽  
Lung Cancer Patients ◽  
Gi Symptoms

Cancer patients receiving chemotherapy have a high risk of malnutrition secondary to the disease and treatment, and 40–80 % of cancer patients suffer from different degrees of malnutrition, depending on tumour subtype, location, staging and treatment strategy. Malnutrition in cancer patients affects the patient's overall condition, and it increases the number of complications, the adverse effects of chemotherapy and reduces the quality of life. The aim of the present study was to evaluate weight-loss prevalence depending on the tumour site and the gastrointestinal (GI) symptoms of oncology patients receiving chemotherapy. We included 191 cancer patients receiving chemotherapy. Files of all patients were reviewed to identify symptoms that might potentially influence weight loss. The nutritional status of all patients was also determined. The cancer sites in the patients were as follows: breast (31·9 %); non-colorectal GI (18·3 %); colorectal (10·4 %); lung (5·8 %); haematological (13·1 %); others (20·5 %). Of these patients, 58 % experienced some degree of weight loss, and its prevalence was higher among the non-colorectal GI and lung cancer patients. Common symptoms included nausea (59·6 %), anorexia (46 %) and constipation (31·9 %). A higher proportion of patients with ≥ 5 % weight loss experienced anorexia, nausea and vomiting (OR 9·5, 2·15 and 6·1, respectively). In conclusion, these results indicate that GI symptoms can influence weight loss in cancer patients, and they should be included in early nutritional evaluations.

Quality of Life in Patients Receiving High-Dose Interferon Alfa-2b After Resected High-Risk Melanoma

2009 ◽  
Vol 27 (24) ◽  
pp. e70-e70 ◽  
Author(s):  
Peter Mohr ◽  
Axel Hauschild ◽  
Uwe Trefzer ◽  
Michael Weichenthal
Keyword(s):  
Quality Of Life ◽  
High Risk ◽  
Interferon Alfa ◽  
High Dose ◽  
High Risk Melanoma ◽  
Risk Melanoma ◽  
High Dose Interferon

scholarly journals Letting Kids Be Kids: A Quality Improvement Project to Deliver Supportive Care at Home After High-Dose Methotrexate in Pediatric Patients With Acute Lymphoblastic Leukemia

2020 ◽  
Vol 37 (3) ◽  
pp. 212-220 ◽  
Author(s):  
Lori Ranney ◽  
Mary C. Hooke ◽  
Kathryn Robbins
Keyword(s):  
Quality Of Life ◽  
Quality Improvement ◽  
Acute Lymphoblastic Leukemia ◽  
High Risk ◽  
Supportive Care ◽  
Lymphoblastic Leukemia ◽  
High Dose ◽  
High Dose Methotrexate ◽  
Dose Methotrexate

The Children’s Oncology Group recommends children with high-risk acute lymphoblastic leukemia (ALL) receive high-dose methotrexate (HD MTX) throughout treatment. Historically, patients have been hospitalized for at least 54 hours for HD MTX. Literature supports the safety and efficacy of the transition of supportive care interventions of intravenous (IV) fluids and leucovorin to ambulatory care. The goal of this quality improvement (QI) project was to implement a system to support the safe delivery of supportive care in the home after inpatient HD MTX in children with high-risk ALL. An interdisciplinary team implemented system changes including an ambulatory supportive care protocol, standard computerized order sets, family education, and education of staff in the inpatient, outpatient, and home care setting. Measurements included laboratory results of renal function and medication clearance, length of hospitalization, and family-reported quality of life. During project implementation, 10 patients completed a total of 38 cycles. The system safely and effectively supported transition to the outpatient setting for all patients. Average length of stay was decreased by 37.8 hours per HD MTX cycle. Families reported that quality of life improved in most domains with family time and sleep having largest improvement, while level of stress remained the same. Ambulatory monitoring post-HD MTX requires a multidisciplinary approach to meet individualized patient needs. Future QI efforts should consider outpatient administration of HD MTX in addition to supportive care as a means to improved quality of life.

Quality-of-life-adjusted survival analysis of interferon alfa-2b adjuvant treatment of high-risk resected cutaneous melanoma: an Eastern Cooperative Oncology Group study.

1996 ◽  
Vol 14 (10) ◽  
pp. 2666-2673 ◽  
Author(s):  
B F Cole ◽  
R D Gelber ◽  
J M Kirkwood ◽  
A Goldhirsch ◽  
E Barylak ◽  
...  
Keyword(s):  
Quality Of Life ◽  
High Risk ◽  
Eastern Cooperative Oncology Group ◽  
Tumor Burden ◽  
High Dose ◽  
Ifn Alpha ◽  
High Risk Melanoma ◽  
Risk Melanoma ◽  
Relative Value

PURPOSE To evaluate the quality-of-life effects of adjuvant high-dose interferon alfa-2b (IFN alpha 2b) treatment of high-risk melanoma. PATIENTS AND METHODS A quality-of-life-adjusted survival analysis (Quality-Adjusted Time Without Symptoms, and Toxicity [Q-TWiST]) was applied to the Eastern Cooperative Oncology Group Trial E1684, which compared high-dose IFN alpha 2b treatment for 1 year versus observation in 280 high-risk patients. IFN alpha 2b was administered at a dosage of 20 mU/m2 intravenously daily for 5 days per week for 4 weeks, and then three times weekly at 10 mU/m2 subcutaneously for 48 weeks. RESULTS After 84 months of median follow-up time, the IFN alpha 2b group gained a mean of 8.9 months without disease relapse (P = .03) and 7.0 months of overall survival (P = .07) as compared with the observation group, but had severe treatment-related toxicity for 5.8 months, on average. The IFN alpha 2b group had more quality-of-life-adjusted time than the observation group regardless of the relative valuations placed on time with toxicity (Tox) and time with relapse (Rel). This gain was significant (P < .05) for patients who consider Tox to have a high relative value and Rel to have a low relative value. In contrast, for patients who value Tox about the same as Rel, the quality-adjusted gain for IFN alpha 2b was not statistically significant. An analysis stratified according to tumor burden indicated that the benefit of IFN alpha 2b was greatest in the node-positive strata. CONCLUSION For patients with high-risk melanoma, the clinical benefits of high-dose IFN alpha 2b can offset the toxic effects. The optimal treatment for an individual patient depends on the patient's tumor burden and preferences regarding toxicity and disease relapse.

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