Platelet Transfusion for Patients With Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update.

Purpose To provide evidence-based guidance on the use of platelet transfusion in people with cancer. This guideline updates and replaces the previous ASCO platelet transfusion guideline published initially in 2001. Methods ASCO convened an Expert Panel and conducted a systematic review of the medical literature published from September 1, 2014, through October 26, 2016. This review builds on two 2015 systematic reviews that were conducted by the AABB and the International Collaboration for Transfusion Medicine Guidelines. For clinical questions that were not addressed by the AABB and the International Collaboration for Transfusion Medicine Guidelines (the use of leukoreduction and platelet transfusion in solid tumors or chronic, stable severe thrombocytopenia) or that were addressed partially (invasive procedures), the ASCO search extended back to January 2000. Results The updated ASCO review included 24 more recent publications: three clinical practice guidelines, eight systematic reviews, and 13 observational studies. Recommendations The most substantial change to a previous recommendation involved platelet transfusion in the setting of hematopoietic stem-cell transplantation. Based on data from randomized controlled trials, adult patients who undergo autologous stem-cell transplantation at experienced centers may receive a platelet transfusion at the first sign of bleeding, rather than prophylactically. Prophylactic platelet transfusion at defined platelet count thresholds is still recommended for pediatric patients undergoing autologous stem-cell transplantation and for adult and pediatric patients undergoing allogeneic stem-cell transplantation. Other recommendations address platelet transfusion in patients with hematologic malignancies or solid tumors or in those who undergo invasive procedures. Guidance is also provided regarding the production of platelet products, prevention of Rh alloimmunization, and management of refractoriness to platelet transfusion ( www.asco.org/supportive-care-guidelines and www.asco.org/guidelineswiki ).

Phase II study of tolerance and efficacy of hyperfractionated radiotherapy and 5-fluorouracil, cisplatin, and paclitaxel (Taxol) in stage III and IV inoperable and/or unresectable head-and-neck squamous cell carcinoma: A-2 protocol.

PURPOSE: To determine the toxicity and efficacy of concurrent 5-fluorouracil (5-FU), cisplatin, and paclitaxel (Taxol) and hyperfractionated radiotherapy in locally advanced squamous cell carcinoma of the head and neck. METHODS AND MATERIALS: Twenty-seven patients were entered into this Phase II trial. Eligible patients had Stage III or IV head-and-neck squamous cell carcinoma arising from the oral cavity, hypopharynx, oropharynx, nasopharynx, or larynx. The plan of treatment consisted of hyperfractionated radiotherapy (74.4 Gy at twice daily fractions of 1.2 Gy). Chemotherapy was given on Weeks 1, 5, and 8 as follows: 5-FU at 750 mg/m2 as a constant infusion for 24 h for 3 days; cisplatin at 50 mg/m2 in 250-500 mL D5 0.5 NS or NS infusion during 2-4 h, and paclitaxel at 70 mg/m2 infused in 500 mL NS during 3 h. RESULTS: The overall survival rate of the entire group was 81.5%, 66.7%, and 63% at 1, 2, and 3 years, respectively. The median follow-up was 40.2 months (range 30-62). Of the 27 patients, 19 (70%) had a complete response and an overall survival rate of 100% at 1 year and 94% at 2 and 3 years. The disease-free survival rate of the latter group was 95% at 1 year and 84% at 2 and 3 years. Of the 27 patients, 18 (67%) maintained the complete response until the last follow-up visit or death. Percutaneous endoscopic gastrostomy dependency occurred for a median of 7.1 months. Grade 3 and 4 mucositis occurred in 20 and 3 patients, respectively. Six patients were hospitalized for leukopenic fever. Late toxicities included L'Hermitte syndrome (n = 3), osteoradionecrosis (n =1), hypothyroidism (n = 4), paresthesias (n = 1), aspiration pneumonia (n = 3), and esophageal strictures (8 patients underwent dilation). CONCLUSION: Combining hyperfractionated radiotherapy concurrently with 5-FU, cisplatin, and paclitaxel results in acceptable efficacy and toxicity. However, although a locoregional control benefit is suggested by the preliminary results of this trial, it needs to be confirmed in a prospective randomized trial.

Radiation technique influence on percutaneous endoscopic gastrostomy tube dependence: Comparison between two radiation schemes.

BACKGROUND: Our aim was to determine whether percutaneous endoscopic gastrostomy (PEG) dependence was significantly different between 2 prospective trials with different radiation fractionation schemes. METHODS: Stage III or IV locally advanced head and neck squamous cell carcinomas arising from the oral cavity, hypopharynx, oropharynx, nasopharynx, paranasal sinuses, or larynx were treated using hyperfractionation (A-3 protocol) or accelerated fractionation (A-4 protocol) with chemotherapy. Amifostine was administered 15 to 30 minutes preradiation, at a dose of 500 mg/day in both protocols. It was given as an infusion over 5 to 7 minutes (A-3 protocol) or subcutaneously (A-4 protocol). Data regarding PEG placement and removal were collected prospectively. RESULTS: Thirty-five evaluable A-3 protocol patients, 14 evaluable A-4 protocol patients, and 6 patients treated per A-4 protocol guidelines, but without amifostine as they refused the medication, were included in the analysis. Pretreatment characteristics, such as sex, age, race, T classification, N classification, American Joint Committee on Cancer (AJCC) stage, were compared between the 2 groups of patients. The only significant difference between the 2 groups was AJCC stage. Thirty-five A-3 patients and 20 A-4 patients had overall survivals of 88% versus 80%, 82% versus 75%, and 66% versus 67.5% at 1, 2, and 3 years, respectively (p = .958). With regard to PEG dependence, no significant differences were seen between the 2 groups at 6, 12, or 18 months. CONCLUSION: PEG dependence was not significantly different between the 2 study groups. Type of altered fractionation scheme may not influence PEG dependence in patients treated with similar protocols. Future randomized studies are needed to confirm these findings.

Quality-of-life assessment after hyperfractionated radiation therapy and 5-fluorouracil, cisplatin, and paclitaxel (Taxol) in inoperable and/or unresectable head and neck squamous cell carcinoma.

PURPOSE: To determine quality of life (QOL) after hyperfractionated radiation and chemotherapy. MATERIALS AND METHODS: Functional Assessment of Cancer Therapy (FACT) and the Functional Assessment of Cancer Therapy-Head and Neck (FACT H-N) questionnaires were administered to protocol patients at baseline study entry, during and at the completion of therapy, and during subsequent follow-up. RESULTS: Twenty-four patients completed baseline QOL questionnaires. Six subsequent assessments were given to patients who were available for follow-up. Social/family well-being and relationship with doctor subscores were not significantly different from baseline. Emotional well-being was not different from baseline initially, but actually showed a significant increase 6 months after completion of radiation, seen on assessments 5 and 6 (P < 0.01). Physical and functional well-being subscores, total FACT-G score, head and neck subscores, and total FACT H-N score all showed initial decreases during, at the completion of radiation, or, in some subscores, up to 3 months postradiation. However, all these scores recovered to baseline levels. These scores subsequently showed a significant increase after 6 months to 1 year in all but the physical well-being and head and neck subscores, which remained at baseline. CONCLUSION: QOL scores returned to baseline levels or increased at 6 to 12 months postradiation in long-term survivors who completed QOL questionnaires.

Phase II study of tolerance and efficacy of hyperfractionated radiation therapy and 5-fluorouracil, cisplatin, and paclitaxel (taxol) and amifostine (ethyol) in head and neck squamous cell carcinomas: A-3 protocol.

The objective of this study was to determine the toxicity and efficacy of the current phase II chemoradiation protocol. Stage III or IV locally advanced head and neck squamous cell carcinomas arising from the oral cavity, hypopharynx, oropharynx, nasopharynx, paranasal sinuses, or larynx were treated using hyperfractionated radiation (74.4 Gy at twice-daily fractions of 1.2 Gy) in combination with a 5-fluorouracil, cisplatin, paclitaxel regimen, and an amifostine infusion. Thirty-five of 36 eligible patients were evaluable. The overall survival (OVS) was 88%, 82%, and 66% at 1, 2, and 3 years respectively. Twenty-five patients (71%) had a complete response, which was maintained in 20 (57%) patients until last follow up or death. Disease-free survival (DFS) of the complete responders was 92% at 1 year and 77% at 2 years and 3 years, respectively. Percutaneous endoscopic gastrostomy dependency lasted for a median of 7 months. Grade 3 and 4 mucositis occurred in 23 and 3 patients, respectively. Comparison with a similar study (A-2) that did not include amifostine showed no significant benefit to the addition of amifostine in these patients. A locoregional control benefit should be confirmed in a prospective, randomized trial. Alternative amifostine delivery methods should be investigated.