Assessing cumulative acute toxicity of chemoradiotherapy in head and neck cancer with or without induction chemotherapy.

BACKGROUND: To compare cumulative acute toxicity in head and neck cancer patients treated with concurrent chemoradiotherapy alone (CCRT) versus induction chemotherapy (IC) followed by CCRT (I/CCRT). METHODS: 77 patients underwent definitive CCRT (30 I/CCRT and 47 CCRT). Toxicity was graded using the Common Terminology Criteria for Adverse Events version 4.0. Using the TAME adverse event reporting system, short-term toxicity (T) scores were generated for IC (TIC), CCRT (TCCRT), total treatment duration (TRx), post-treatment period (TPT) and an overall score (Toverall) from treatment start to post treatment period. RESULTS: Acute toxicity other than dysphagia, odynophagia, or dermatitis was reported in 90.0% and 66.0% of I/CCRT and CCRT patients, respectively (P=0.02). Compared to CCRT group, I/CCRT patients reported greater mean TRx (TRx: 2.11 vs. 2.87, P=0.01) and Toverall (Toverall: 2.60 vs. 3.70, P=0.003). CONCLUSION: I/CCRT patients reported more cumulative acute toxicity during treatment compared to CCRT patients using the TAME reporting system.

Unusual tumor response and toxicity from radiation and concurrent erlotinib for non-small-cell lung cancer.

We report a case of a never-smoker female with non-small-cell lung cancer (NSCLC) who experienced a striking tumor response to combined low-dose radiation and the epidermal growth factor receptor inhibitor erlotinib, even though erlotinib alone was not effective in preventing tumor progression. Furthermore, the patient developed symptomatic pneumonitis, which is unusual for the small volume of lung that was exposed to a significant dose of radiation. This case demonstrates that combination therapy with radiation and erlotinib has the potential to significantly benefit a subset of patients with NSCLC in addition to those approximately 10% who have tumors which respond to erlotinib alone. It also highlights the potential risks of molecular targeted radiation therapy.

Palliative radiation therapy of symptomatic recurrent bladder cancer.

BACKGROUND: Palliative radiation therapy (RT) is an established tool in the management of symptoms caused by malignancies. RT is effective at palliating both locally advanced and metastatic cancer, including related symptoms of pain, bleeding, or obstruction. Most data on palliative RT is in regard to its use in the treatment of painful bone metastases. There are also data that support RT palliation for locally advanced or recurrent rectal, prostate, and gynecological cancers. With regard to bladder cancer there is some evidence of the benefit of palliative RT for the control of urinary symptoms and hematuria; however, there is little evidence for the use of palliative RT for pain associated with locally recurrent bladder cancer. We report a case of locally advanced recurrent bladder cancer which was refractory to medical pain management, and was found to be highly responsive to palliative RT. CASE REPORT: An 80-year-old woman with recurrent bladder cancer and intractable pelvic pain refractory to oral and transdermal pain medications, received palliative pelvic RT to a dose of 50 Gy (5000 cGy) in 25 fractions with complete resolution of pain. The patient was originally found to have dysuria, frequency, and hematuria, secondary to an invasive high grade transitional cell carcinoma of the bladder with an adenocarcinoma component, AJCC pT2b N1 M0 Stage IV, for which she underwent a radical cystectomy, total abdominal hysterectomy, bilateral salpingo-oophorectomy, partial vaginectomy, and ileal conduit reconstruction. After undergoing 4 cycles of adjuvant chemotherapy, the patient did well for 5 months with no evidence of symptomatic, clinical, or radiographic recurrence of disease. Repeat staging CT of the abdomen and pelvis confirmed tumor recurrence in the left pelvis. The patient was treated with another course of chemotherapy and pain was managed with relatively low doses of opioid medication (25mcg transdermal fentanyl patch, and oxycodone 5mg bid). However at the fourth month, there was rapid escalation of severe pain with the patient becoming bed bound due to pain with an associated decrease in ambulation and anorexia. Ultimately a pain medication regimen of 200mcg transdermal fentanyl patch q2 days, oxycontin 20mg bid, oxycodone 5 - 10mg q 4 hours, ibuprofen 400mg q 8 hours, and gabapentin 600mg TID was not effective in controlling pain. The patient was then referred to Radiation Oncology 6 months after the pain initially began for evaluation. She received a total of 5000cGy over 25 fractions to a small pelvis field over 5 weeks and reported complete pain resolution. She was able to decrease pain medications, increase overall activity, and gain significant improvement in sleep quality and appetite even early on in the course of her radiation therapy. CONCLUSIONS: Palliative radiation therapy has been well studied in the setting of bone metastases and treatment of hematuria for locally advanced bladder cancer. There is little data that we are aware of on the use of RT for pain control with patients that have recurrent, locally advanced bladder cancer. We have presented a case in which an excellent outcome in pain control was seen for a patient with medically unmanageable pain. RT is an excellent option for pain management in recurrent bladder cancer and should be offered to patients whose pain is not otherwise optimally controlled. Palliative RT is an important component in the multimodality approach to cancer pain management and optimization of quality of life.

Analysis of decision making at a multidisciplinary head and neck tumor board incorporating evidence-based National Cancer Comprehensive Network (NCCN) guidelines.

PURPOSE: To evaluate incorporation of National Cancer Comprehensive Network (NCCN) guidelines in decision making at a head and neck cancer (HNC) multidisciplinary tumor board (MDT) at an urban academic medical center. METHODS AND MATERIALS: A retrospective study of 176 HNC patients was performed. The extent to which MDT decisions and subsequent patient care incorporate NCCN guidelines was evaluated. RESULTS: A total of 173 (98.3%) HNC patients received MDT recommendations according to NCCN guidelines. Of the 159 patients treated, 153 (96.2%) received treatment according to NCCN guidelines. The MDT recommended the highest available evidence-based NCCN category guideline in 78.0%. Subsequent treatment using the same or higher category MDT recommendation occurred in 87.0% of patients. CONCLUSIONS: Evaluation of patients at an MDT using NCCN guidelines incorporates the highest level of evidence in approximately 80% of patients and translates well into subsequent care. Incorporation of the highest available NCCN guideline may be improved, although management should be individualized.

The influence of limited English proficiency on outcome in patients treated with radiotherapy for head and neck cancer.

OBJECTIVE: To evaluate how limited English proficiency affects treatment outcome in head and neck cancer (HNC) patients treated with curative intent radiation therapy (RT). METHODS: From 2004 to 2010, 131 patients with HNC underwent RT. Patient's self-reported primary language and race/ethnicity were obtained at hospital registration. English proficiency was categorized as being English proficient (EP) or limited English proficient (LEP). Race/ethnicity was categorized as white, black and other (Hispanics and Asians). Patients were evaluated for locoregional (LRC), distant control (DC), overall (OS) and disease-free (DFS) survival. RESULTS: Fewer LEP patients (60.0%) underwent chemoradiation compared to EP (83.8%), P=0.028. The three-year actuarial LRC for EP and LEP patients was 82.2% and 58.3%, respectively, P=0.038. LEP patients had an increased risk of locoregional failure on univariate Cox regression analysis (hazard ratio, HR 2.4, 95% CI, 1.0-5.8). No differences by English proficiency were seen for DC, OS and DFS. Race/ethnicity was not associated LRC, DC, OS and DFS. CONCLUSION: Inferior locoregional control was observed in LEP patients receiving RT for HNC. Potential health disparities as a result of limited English proficiency require further investigation. PRACTICE IMPLICATIONS: Patient education, use of culturally sensitive interpreter and patient navigation services, and improved patient compliance should be considered in head and neck cancer patients receiving complex multidisciplinary care.

Health behaviors, readiness to change, and interest in health promotion programs among smokers with lung cancer and their family members: a pilot study.

BACKGROUND: The diagnosis of lung cancer presents an opportunity to motivate individuals to adopt health-promoting behavior. Little attention has been given to using this opportunity to also motivate relatives to change their health behaviors. OBJECTIVES: The objectives of this study were to describe health behaviors and readiness to change lifestyle, identify interest in health promotion programs, and examine concordance of health behaviors among smokers with lung cancer and their family members. METHODS: Cross-sectional data were collected once from 37 lung cancer patient-family member dyads. Standardized questionnaires were used to collect data. Descriptive statistics and percent agreement were used for analyses. RESULTS: Lung cancer patients and their family members had high rates of continued smoking (43% vs 30%), low intake of fruits and vegetables (92% vs 95%), and high rates of physical inactivity (84% vs 84%). Patients and family members indicated readiness to change behaviors within the next 6 months ranging from 63% for physical activity, 73% for diet, and 88% to quit smoking for patients and 81% for physical activity, 58% for diet, and 91% to quit smoking for family members. Interest in participating in a multiple behavioral risk reduction program was high for patients and family members. CONCLUSIONS: The majority of patients and their family members have multiple behavioral risk factors placing them at risk for poor health outcomes. IMPLICATIONS FOR PRACTICE: Oncology nurses are in a unique position to provide leadership in assessing health behaviors and implementing evidence-based interventions to enhance outcomes for patient-family member dyads with lung cancer.

Creating computable algorithms for symptom management in an outpatient thoracic oncology setting.

CONTEXT: Adequate symptom management is essential to ensure quality cancer care, but symptom management is not always evidence based. Adapting and automating national guidelines for use at the point of care may enhance use by clinicians. OBJECTIVES: This article reports on a process of adapting research evidence for use in a clinical decision support system that provided individualized symptom management recommendations to clinicians at the point of care. METHODS: Using a modified ADAPTE process, panels of local experts adapted national guidelines and integrated research evidence to create computable algorithms with explicit recommendations for management of the most common symptoms (pain, fatigue, dyspnea, depression, and anxiety) associated with lung cancer. RESULTS: Small multidisciplinary groups and a consensus panel, using a nominal group technique, modified and subsequently approved computable algorithms for fatigue, dyspnea, moderate pain, severe pain, depression, and anxiety. The approved algorithms represented the consensus of multidisciplinary clinicians on pharmacological and behavioral interventions tailored to the patient's age, comorbidities, laboratory values, current medications, and patient-reported symptom severity. Algorithms also were reconciled with one another to enable simultaneous management of several symptoms. CONCLUSION: A modified ADAPTE process and nominal group technique enabled the development and approval of locally adapted computable algorithms for individualized symptom management in patients with lung cancer. The process was more complex and required more time and resources than initially anticipated, but it resulted in computable algorithms that represented the consensus of many experts.

Impact of neoadjuvant chemoradiotherapy followed by surgical resection on node-negative T3 and T4 non-small cell lung cancer.

OBJECTIVE: This study examined the impact of neoadjuvant chemotherapy and concurrent high-dose radiation therapy on survival in patients with node-negative T3 and T4 non-small cell lung cancer. METHODS: A total of 110 consecutive patients underwent surgical resection for invasive T3N0M0 (94 patients) and T4N0M0 (16 patients) non-small cell lung cancer between 1979 and 2008. Forty-seven patients received neoadjuvant chemotherapy and concurrent high-dose (5940 cGy) radiation therapy before resection (Chemo-RT group). Sixty-three patients underwent surgical resection without receiving induction chemoradiotherapy (Surg group), of whom 21 received neoadjuvant radiation, 19 received adjuvant radiation, 17 received surgery alone, 2 received adjuvant chemotherapy, 2 received adjuvant chemoradiotherapy, and 2 received brachytherapy. Survival of the Chemo-RT and Surg groups was compared using both crude and adjusted Cox proportional hazards models. RESULTS: The 5-year, 10-year, and median survivals were 61%, 50%, and 90 months, respectively, in the Chemo-RT group versus 22%, 14%, and 22 months, respectively, in the Surg group. Subjects in the Surg group had an increased risk of death (hazard ratio, 2.60; 95% confidence interval, 1.62-4.18; P = .0001) compared with the Chemo-RT group. After adjustment for potential confounding variables of age, sex, tumor size, tumor location, type of operation, and decade of care, subjects in the Surg group remained at increased risk of death (hazard ratio, 2.81; 95% confidence interval, 1.45-5.44, P = .002) compared with the Chemo-RT group. CONCLUSIONS: Aggressive treatment of node-negative invasive T3 and T4 NSCLC with induction chemoradiotherapy may significantly prolong survival. This approach should be evaluated in a prospective multicenter national trial.

Phase II trial of weekly paclitaxel and gemcitabine for previously untreated, stage IIIB-IV nonsmall cell lung cancer.

BACKGROUND: The purpose of the current study was to evaluate the efficacy and tolerance of the noncisplatin-based combination of paclitaxel and gemcitabine administered weekly for patients with untreated metastatic nonsmall cell lung cancer (NSCLC). METHODS: Patients with Stage IIIB/IV or recurrent NSCLC, a performance status of 0-2, and no prior chemotherapy exposure were eligible. Patients received gemcitabine 1000 mg/m2 and paclitaxel 85 mg/m2 on Days 1, 8, 15, 22, 29, 36 of an 8-week cycle until progression. RESULTS: Thirty-nine eligible patients were enrolled. The median age was 66 years and 14 patients were > or =70 years old. Performance status was 2 in 13 (33%) and 29 patients (75%) had Stage IV. Five patients (12.8%) developed interstitial pneumonitis and 2 of these were responsive to steroid therapy. The overall response rate was 23.1%, with no complete responses. The median survival was 32 weeks and the 1-year survival was 32%. CONCLUSIONS: This regimen of weekly paclitaxel and gemcitabine has modest activity in advanced NSCLC.

Phase II trial of erlotinib in gastroesophageal junction and gastric adenocarcinomas: SWOG 0127.

PURPOSE: A phase II trial of the oral epidermal growth factor receptor (EGFR) inhibitor erlotinib in patients with gastroesophageal adenocarcinomas stratified according to primary tumor location into two groups: gastroesophageal junction (GEJ)/cardia and distal gastric adenocarcinomas. PATIENTS AND METHODS: Patients with a histologically proven diagnosis of adenocarcinoma of the GEJ or stomach (ST) that was unresectable or metastatic; presence of measurable disease; no prior chemotherapy for advanced or metastatic cancer; Zubrod performance status (PS) of 0 to 1; and adequate renal, hepatic, and hematologic function were treated with erlotinib 150 mg/d orally. Patient characteristics were median age, GEJ-63 years, ST-64 years; sex, GEJ-84% male and 16% female, ST-60 male and 40 female; Zubrod PS, GEJ-25 had a PS of 0 and 18 had a PS 1, ST-13 had a PS of 0 and 12 had a PS of 1. RESULTS: Percentage of common toxicities were skin rash, 86% and 72%; fatigue, 51% and 44%; and AST/ALT elevation, 28% and 28%, respectively for GEJ and ST. There has been one confirmed complete response, three confirmed partial responses (PRs) and one unconfirmed PR for an overall response probability of 9% confirmed (95% CI, 3% to 22%), all occurring in GEJ stratum. No responses were observed in ST stratum. The median survival was 6.7 months in GEJ and 3.5 months in ST stratum. Neither intratumoral EGFR, transforming growth factor-alpha or phosphorylated Akt kinase expression nor plasma proteomic analyses were predictive of clinical outcome. No somatic mutations of the EGFR exons 18, 19, or 21 were detected and there was no gross amplification of EGFR by fluorescence in situ hybridization. CONCLUSION: Erlotinib is active in patients with GEJ adenocarcinomas, but appears inactive in gastric cancers. The molecular correlates examined were not predictive of the patient therapeutic response.