Outpatient intra-arterial chemotherapy without radiation therapy for stages II and III oral cancer: A new treatment to improve quality of life and reduce irradiation-related complications.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e17567-e17567
Author(s):  
Masatoshi Ohmae ◽  
Itsuro Kato ◽  
Yusei Fujita ◽  
Hiroo Takaoka ◽  
Noritoshi Meshii ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Radiation Therapy ◽  
Oral Cancer ◽  
Regional Lymph Node ◽  
Performance Status ◽  
Superficial Temporal Artery ◽  
Dry Mouth ◽  
Occipital Artery ◽  
Curative Effect

e17567 Background: We developed a superselective intra-arterial chemotherapy (iaCT) approach to oral cancer, in which an intra-arterial catheter is retrogradely inserted through the superficial temporal artery and/or occipital artery with concurrent radiation therapy (RT). This approach remarkably improves the curative effect, but it decreases patients’ quality of life (QOL) because of prolonged hospitalization, severe stomatitis, lifelong dry mouth, dysgeusia, and radiation osteonecrosis of the maxillo-mandibular bone. Methods: This study assessed our new outpatient iaCT (op-iaCT) approach involving a subcutaneous infusion reservoir without concurrent RT. We included 23 patients, 11 with stage II and 12 with stage III oral cancer, and they were treated with the op-iaCT approach without concurrent RT. Using this approach, the chemotherapeutic agent was intra-arterially administered at the Outpatient Chemotherapy Center of Rinku General Medical Center. Results: The response rate to this approach was 100%, and all patients had a complete response. Four patients with secondary regional lymph node metastasis underwent neck dissection. Twenty patients were disease-free without an irradiation-related complication, whereas 3 patients died of distant metastasis (2) or local recurrence (1). With the exception of ambulatory visits twice per week for 3 weeks, patients’ activities of daily living (ADLs) were mostly unaffected. Moreover, patients rarely complained of dry mouth or dysgeusia, and they were free from radiation osteonecrosis after cancer therapy. Additionally, they did not develop oral dysfunction related to radical operation. Conclusions: In this approach, the catheter is implanted subcutaneously; therefore, common catheter-related issues rarely occur, resulting in good maintenance of ADLs. Moreover, patients can avoid the side effects of RT. Consequently, patient’s QOL improves and medical expenses decrease. Thus, our new op-iaCT approach improves QOL and the curative effect in patients with oral cancer if their ambulatory and performance status is good.

Superselective intra-arterial chemotherapy for oral cancer by subcutaneous implantation of an intra-arterial catheter and an infusion reservoir: A new chemotherapy method to improve the quality of life and curative effect.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6096-6096
Author(s):  
Masatoshi Ohmae ◽  
Iwai Tohnai ◽  
Itsuro Kato ◽  
Mitsuhiro Nakazawa
Keyword(s):  
Quality Of Life ◽  
Oral Cancer ◽  
Performance Status ◽  
Superficial Temporal Artery ◽  
Arterial Catheter ◽  
Mastoid Process ◽  
Occipital Artery ◽  
Subcutaneous Infusion ◽  
Outpatient Chemotherapy

6096 Background: We have developed a superselective intra-arterial chemotherapy (iaCT) approach for oral cancer, in which intra-arterial catheter is retrogradely inserted via the superficial temporal artery (STA) and/or occipital artery (OA). This approach increases chemotherapy efficiency but remarkably decreases activities of daily living (ADL) because the catheter penetrates the skin over the approaching artery (STA/OA). Methods: This study assessed our new outpatient iaCT approach involving implantation of an intra-arterial catheter connected to a subcutaneous infusion reservoir. We included 10 patients who had oral cancer treated using outpatient iaCT: tongue carcinoma, 7; cheek mucosal carcinoma, 1; upper gingival carcinoma, 1; palatal carcinoma, 1. In this approach, the STA or OA or both were percutaneously dissected out, a catheter was inserted, and the catheter tip was superselectively placed in the tumor-feeding artery. The extra-arterial catheter portion was implanted through a subcutaneous tunnel and was connected to a subcutaneous infusion reservoir implanted around the mastoid process. The patients were discharged after catheterization, and the chemotherapeutic agent was intra-arterially administered at the Outpatient Chemotherapy Center of Rinku General Medical Center once or twice a week. Intra-arterial infusion was repeated 6 times per course. Results: The response rate was 100%, i.e., 8 cases of CR and 2 of PR; patients with PR underwent surgery.Their ADLs were scarecely disturbed exept for ambulatory visits. Conclusions: In this approach, the catheter is completely implanted subcutaneously; therefore, usual catheter-related issues (e.g., infection, catheter fall out) rarely occur. Because this leads to very good ADLs, outpatient chemotherapy can be safely performed. Consequently, the quality of life (QOL) improves and medical expenses decrease.Our new outpatient iaCT approach improves QOL of and curative effects for oral cancer patients if the ambulatory convenience and the performance status are good.

Long-term result of out-patient intra-arterial chemotherapy in patients with stage II and III oral cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e17569-e17569
Author(s):  
Masatoshi Ohmae ◽  
Itsuro Kato ◽  
Yusei Fujita ◽  
Hiroo Tkaoka ◽  
Noritoshi Meshii ◽  
...  
Keyword(s):  
Survival Rate ◽  
Oral Cancer ◽  
Neck Dissection ◽  
Regional Lymph Node ◽  
Superficial Temporal Artery ◽  
Stage Ii ◽  
Mastoid Process ◽  
Occipital Artery ◽  
Long Term Outcome

e17569 Background: We have developed a superselective intra-arterial chemotherapy (iaCT) approach for oral cancer, in which intra-arterial catheter is retrogradely inserted via the superficial temporal artery and/or occipital artery. The extra-arterial portion of catheter is connected to an infusion reservoir implanted subcutaneously around the mastoid process through the subcutaneous tunnel. The catheter and reservoir are completely placed under the skin, so there is little possibility of catheter-related issues such as infection and displacement. Hence, out-patient iaCT (op-iaCT) can be performed. This method has improved ADL of patients without any loss of curative effect and oral function. We reported the usefulness of op-iaCT at the ASCO annual meeting in 2013. We assessed the long-term outcome and survival rate of patients with stage II and III oral cancer who received op-iaCT and survived for at least 5 years. Methods: We have used op-iaCT for 46 patients who had oral cancer, out of which we selected 14 patients with stage II and III oral cancer, and monitored them for more than 5 years. Results: Two patients died owing to distant metastasis, to the brain and liver, and 12 patients were cancer-free. Neck metastases were detected after primary treatment and op-iaCT in 3 patients, who were salvaged by neck dissection. The 5-year survival rate was 86%. Conclusions: Distant and/or regional lymph node metastases were observed in 5 out of 14 patients. The op-iaCT improves quality of life of patients with stage II and III oral cancer, but the metastasis rate is somewhat high. Close observation, intravenous chemotherapy, and /or prophylactic neck dissection should be employed in the op-iaCT approach for oral cancer.

scholarly journals PO-0664: Dry mouth and sticky saliva- Quality of life domains most affected in the acute toxicity phase of radiation therapy

2013 ◽  
Vol 106 ◽  
pp. S255
Author(s):  
S. Tribius ◽  
M.C. Raguse ◽  
C. Voigt ◽  
C. Woywod ◽  
A. Kruell ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Radiation Therapy ◽  
Acute Toxicity ◽  
Dry Mouth ◽  
Life Domains ◽  
Sticky Saliva

Performance status scale for head and neck scores for oral cancer survivors: predictors and factors for improving quality of life

2018 ◽  
Vol 23 (4) ◽  
pp. 1575-1582 ◽  
Author(s):  
Takahide Kondo ◽  
Akinari Sugauchi ◽  
Yusuke Yabuno ◽  
Hironobu Kobashi ◽  
Katsuhiko Amano ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Oral Cancer ◽  
Cancer Survivors ◽  
Head And Neck ◽  
Performance Status ◽  
Performance Status Scale

Methodology and results of a pain-assessment process for patients receiving radiation therapy treatment.

2017 ◽  
Vol 35 (8_suppl) ◽  
pp. 105-105
Author(s):  
Angela McDuffie ◽  
Eleanor Elizabeth Harris ◽  
Anita Proctor ◽  
Leann Potter ◽  
Timothy Barnes ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Radiation Therapy ◽  
Pain Assessment ◽  
Radiation Treatment ◽  
Performance Status ◽  
Assessment Process ◽  
Successful Implementation ◽  
Patient Pain ◽  
Therapy Treatment

105 Background: Patients receiving radiation therapy treatment often exhibit pain as a consequence of their cancer or treatment, and is a major factor affecting the patient’s quality of life and functional status. Accreditation standards require pain to be assessed and managed, which are key components in successful implementation of a radiation therapy plan of care. Multifactorial causes for cancer pain, the subjective nature of pain assessment, and the protracted nature of radiation delivery make it necessary to routinely evaluate patient pain using quantifiable metrics. These evaluations can then be used to develop and evaluate effectiveness of interventional strategies. Methods: Internal “spot check” chart review in early 2015 showed deficits in 16 of 37 charts (43.2%) reviewed for pain assessments, revealing documentation well below the required threshold (95%). As a result, the Department of Radiation Therapy revised the process for the accepted 10-point intensity scale to evaluate patient pain. This revised process included staff re-education, workflow adjustments, and nursing evaluation prior to, during, and the end of the radiation treatment course using a standardized pain scale form. Documentation was accomplished by means of vital sign template encounter tool used by Nursing at the time of initial consult, for weekly on-treatment visits (OTVs), and end of treatment (EOT) encounter. Results: Data were monitored for the period of April-June 2015 and reported as a continuous quality improvement (CQI) activity to the department’s Quality Committee. Amassed data showed a total of 186 unduplicated patients were treated during this period, and 181 (97.3%) were assessed for pain. Conclusions: Ongoing monitoring is an important strategy to assure complete evaluation, treatment and outcomes of patient pain while receiving radiation treatment. A clearly defined and quantifiable process is important to facilitate monitoring and ongoing pain management. Improvements in consistency of pain assessment and management promote enhanced focus on patient pain and contribute to delivery of care, and patient quality of life and performance status.

High-dose, short-duration, intra-arterial cisplatin therapy for oral cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6038-6038
Author(s):  
Masatoshi Ohmae ◽  
Itsuro Kato ◽  
Yusei Fujita ◽  
Noritoshi Meshii ◽  
Ayako Motoki ◽  
...  
Keyword(s):  
Oral Cancer ◽  
Adverse Events ◽  
Anticancer Agents ◽  
Superficial Temporal Artery ◽  
Dry Mouth ◽  
Arterial Catheter ◽  
Mastoid Process ◽  
High Dose ◽  
Occipital Artery ◽  
Hematologic Toxicity

6038 Background: We developed a superselective intra-arterial chemotherapy (iaCT) approach for oral cancer wherein an intra-arterial catheter is retrogradely inserted via the superficial temporal artery (STA) and/or occipital artery (OA). In most iaCT cases, high-dose anticancer agents are administrated via the intra-arterial catheter weekly or biweekly with daily irradiation. This approach remarkably improves curative efficiency, but some adverse events, e.g., severe mucositis, dysphagia, dysgeusia, dry mouth, and radiation osteonecrosis, mainly because of irradiation, decrease the quality of life. Methods: Thirty-two patients with stage II, III, or IV oral squamous cell carcinoma were treated using this new iaCT approach. The catheter was superselectively placed in the tumor-feeding arteries by cut-down of STA or OA. The catheter was completely placed under the skin and was connected to an infusion reservoir that was subcutaneously implanted around the mastoid process via the subcutaneous tunnel, ensuring little possibility of catheter-related issues such as infection and displacement of catheter. Anticancer agents (30 mg/m2of cisplatin with/without 10 mg/m2of docetaxel) were intra-arterially administered via the reservoir twice a week for 3 weeks, 180 mg/m2/6 times in total, without irradiation. The treatment effect was assessed using computed tomography, positron emission tomography, and biopsy. Results: The response rate of this approach was 100%, with 31 and 1 case having complete response (CR) and partial response (PR), respectively. Five patients with delayed regional lymph node metastasis or PR underwent salvage surgery; 28 patients (87.5%) had disease-free survival, while 2 (6.2%) died due to local recurrence and 2 due to distant metastasis. All patients developed CTCAE v4.0 Grade 2 oral mucositis in the flow area of the intended artery, most of which disappeared in half a year. No dry mouth, dysgeusia, and eating disorder were observed because the patients did not receive radiotherapy. No systemic adverse events such as hematologic toxicity and renal and/or hepatic injuries occurred. Conclusions: This method improved the adverse event of iaCT with radiotherapy, and the main advantage of superselective iaCT was not lost.

The Head and Neck Radiotherapy Questionnaire: a morbidity/quality-of-life instrument for clinical trials of radiation therapy in locally advanced head and neck cancer.

1993 ◽  
Vol 11 (5) ◽  
pp. 863-872 ◽  
Author(s):  
G P Browman ◽  
M N Levine ◽  
D I Hodson ◽  
J Sathya ◽  
R Russell ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Radiation Therapy ◽  
Head And Neck Cancer ◽  
Head And Neck ◽  
Performance Status ◽  
Locally Advanced ◽  
Skin Toxicity ◽  
Head And Neck Radiotherapy

PURPOSE The purpose of this study was to develop and validate an instrument for clinical trials to measure radiation-related acute morbidity and quality of life from the perspective of patients with head and neck cancer (HNC) treated with radiotherapy. METHODS The Head and Neck Radiotherapy Questionnaire (HNRQ) was developed by a panel of health care workers and patients, was pretested in a pilot study of HNC patients, and was validated in a randomized double-blind trial of concomitant fluorouracil (FUra) infusional therapy (1.2 g/m2 per 24 hours) or saline placebo administered for 72 hours in the first and third weeks of a 6 1/2-week course of radiation therapy. The HNRQ was validated against existing toxicity and performance status indices, all of which were measured weekly for the 6 1/2 weeks of treatment and for 4 weeks posttreatment. RESULTS There were three a priori constructs: (1) that the HNRQ scores would conform to a shallow U-shaped pattern to reflect declining quality of life (increasing morbidity) during radiation and recovery posttreatment; (2) that the HNRQ would correlate with existing toxicity indices (World Health Organization [WHO] stomatitis, Byfield stomatitis, WHO skin toxicity, Eastern Cooperative Oncology Group [ECOG] and Karnofsky performance status); and (3) that the HNRQ would discriminate between FUra and placebo groups. The HNRQ and its domain scores all showed a change from baseline reflecting increased morbidity during radiation (analysis of variance [ANOVA], P < .00001). The HNRQ correlated well with all other indices (r > or = .60), and domain scores correlated best with other indices that assess the same symptom complex (eg, HNRQ skin domain and WHO skin toxicity index, r = .77). There was a significant difference in HNRQ scores between the FUra and placebo groups during radiation (ANOVA, P = .0007), and all HNRQ domains also discriminated between the treatment groups. CONCLUSION The HNRQ is a valid measure of acute morbidity due to radiation therapy in patients with locally advanced HNC, and may be useful as an outcome measure for future clinical trials of radiation treatment strategies.

scholarly journals Trans sodium crocetinate with temozolomide and radiation therapy for glioblastoma multiforme

2017 ◽  
Vol 126 (2) ◽  
pp. 460-466 ◽  
Author(s):  
John L. Gainer ◽  
Jason P. Sheehan ◽  
James M. Larner ◽  
David R. Jones
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Radiation Therapy ◽  
Glioblastoma Multiforme ◽  
Phase I ◽  
Phase Ii ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Serious Adverse Events

OBJECTIVE A new drug, trans sodium crocetinate (TSC), has been developed to enhance the delivery of oxygen to hypoxic tissues. Cancerous tumors, such as glioblastoma multiforme (GBM), are very hypoxic, and it has been suggested that radiation therapy (RT) is more beneficial if tumors are better oxygenated. A Phase I/II clinical trial was conducted to determine the effect of adding TSC to RT sessions. METHODS An open, single-arm clinical trial incorporating the standard of care (SOC) for GBM was conducted at 18 clinical sites. There were 6 weeks of RT consisting of 2 Gy/day for 5 days/week, beginning after an initial resection or stereotactic biopsy to confirm GBM. Temozolomide (TMZ), 75 mg/m2, was given before each RT session. The TSC, 0.25 mg/kg, was intravenously administered around 45 minutes before an RT session 3 days/week, usually on Monday, Wednesday, and Friday. A Phase I run-in period included 2 cohorts. The first cohort contained 3 patients who were given a half dose of the intravenous TSC (that is, 0.25 mg/kg, 3 times per week for only the first 3 weeks of RT). After a Safety Monitoring Committee (SMC) had verified that no dose-limiting toxicity (DLT) had occurred, a second cohort of 6 patients was given the same dosage of TSC but for the full 6 weeks of RT. After the SMC verified that no DLTs had occurred, Phase II began, with the administration of the full 18 doses of TSC. Fifty additional patients were enrolled during Phase II. Following the completion of RT, the patients rested for a month. After that, SOC TMZ chemotherapy (150–200 mg/m2) was administered for 5 days of the 1st week of 6 monthly cycles. No TSC was administered during this chemotherapy phase or later in the trial. Any other follow-up therapies were administered at the discretion of the individual investigators. RESULTS Kaplan-Meier analysis showed that 36% of the full-dose TSC patients were alive at 2 years, compared with historical survival values ranging from 27% to 30% for the SOC. Survival for the biopsy-only subset of patients was 40%, as compared with 42.9% for those patients having a complete resection before treatment. In addition, 2 of the 3 Phase I, Cohort 1 patients survived at 2 years. Contrast MRI data suggested that considerable pseudoprogression had occurred. Both Karnofsky Performance Status (KPS) scores and quality of life (QOL) questionnaires indicated that a good quality of life existed for most patients throughout the trial. No serious adverse events occurring in the trial were attributed to TSC. CONCLUSIONS This trial contained a single arm consisting of 59 patients. The results strongly suggested that adding TSC during RT is beneficial for the treatment of GBM. Trans sodium crocetinate offers a novel, easily implemented way to combat hypoxia in tumor tissue. Clinical trial registration no.: NCT01465347 (clinicaltrials.gov)

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