NSABP FC-6: Surgical conversion rate in colorectal cancer patients with unresectable, KRAS wild-type liver metastases receiving mFOLFOX7 plus cetuximab.

PURPOSE: This study sought to determine the R0 resection rate in KRAS wild-type (WT), liver-only metastatic colorectal cancer (CRC) patients initially identified as having unresectable disease who were treated with FOLFOX7 plus cetuximab. Exploratory molecular analyses were undertaken before and after treatment. METHODS: Twenty patients were enrolled. None had prior adjuvant chemotherapy. Cetuximab was added to a FOLFOX7 backbone and administered at 500 mg/m2 every 14 days with dose reductions to 400 and 300 mg/m2 in the event of toxicity. In the absence of toxicity, dose-escalations to 600, 700, and 800 mg/m2 were allowed. The mean dose of cetuximab (mg/m2 /week) throughout the study was 289 mg/m2 . Paired samples were collected for correlative studies, where feasible. RESULTS: We assessed the conversion rates from unresectable to resectable in hepatic-only, KRAS exon 2 WT mCRC. Seventeen of 20 patients undergoing chemotherapy were considered resectable by imaging criteria; R0 resection was achieved in 15/20 patients. Molecular profiling revealed heterogeneity between patients at the gene-expression, pathway signaling, and immune-profile levels. CONCLUSIONS: Although 15/20 (75%) converted to R0 resection, by 2 years, 10/15 R0 resections had recurred. Therefore, chemotherapy plus cetuximab is of limited long-term benefit in this setting. ctDNA analysis may guide additional therapy including immunotherapy.

Symptom concerns and quality of life in hepatobiliary cancers.

PURPOSE/OBJECTIVES: To describe the symptom concerns of patients with hepatocellular carcinoma (HCC) and pancreatic cancer and explore the effect of symptoms on patients' quality of life (QOL). DESIGN: Descriptive, longitudinal study. SETTING: Ambulatory clinics of a comprehensive cancer center. SAMPLE: 45 patients actively receiving treatment for either HCC or pancreatic cancer. METHODS: Patients were followed from baseline for three months, with outcome measures repeated monthly. Outcome measures included the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) and the Functional Assessment of Chronic Illness Therapy-Spirituality Subscale (FACIT-Sp-12). Descriptive analysis of demographic, treatment, and symptom data was conducted, followed by two-way repeated measures analysis of variance of FACT-Hep and FACIT-Sp-12 scale scores by diagnosis and treatment type. MAIN RESEARCH VARIABLES: Symptoms, QOL. FINDINGS: Overall QOL is poor in patients with hepatobiliary cancer, and this trend continues over time. Symptoms such as abdominal pain, fatigue, weight loss, and poor appetite commonly are reported in this population. CONCLUSIONS: Patients with hepatobiliary cancer suffer from multiple symptoms that may have a negative affect on overall QOL. Specific QOL domains, such as physical and functional well-being, are of particular concern for patients. IMPLICATIONS FOR NURSING: The identification of specific symptom and QOL concerns in hepatobiliary cancers will enhance clinical care and aid in the future development of multidisciplinary interventions for this understudied cancer population.

Management of pain and nausea in outpatient surgery.

The cost associated with surgical procedures has been dramatically decreased by the ability to perform these procedures on an outpatient basis. Pain and nausea, two common symptoms after anesthesia and surgical procedures, are among the greatest concerns for patients and their family members. As a result of the distress and sequelae associated with these symptoms, clinicians have attempted to determine the optimal intraoperative and postoperative symptom management for patients. The purpose of this quality improvement project was to describe the incidence of these symptoms and their management in patients who underwent planned outpatient surgical procedures in a cancer center. A sample of 39 patients were accrued at a comprehensive cancer center over a 3-month period. Data were collected at three specific time points (i.e., preoperatively, at 24 hours and at 7 days postoperatively). Postoperative pain and nausea were generally well managed, but improvement was needed in preoperative patient teaching, including the topics of drug and nondrug interventions. The methods used in this project have potential application for the measurement of other clinical outcomes after outpatient surgical procedures.

Improved hepatic toxicity profile of portal vein adjuvant hepatic infusional chemotherapy.

PURPOSE: To determine whether floxuridine (FUDR) can be delivered with low hepatic toxicity through the portal vein (PV) as an adjuvant to surgically treated colorectal metastases. PATIENTS AND METHODS: Fifty-one patients undergoing complete resection and/or ablation for colorectal hepatic metastases were prospectively enrolled at a National Cancer Institute-designated comprehensive cancer center. Two sequential phase II trials were performed. Each trial included complete surgical treatment followed by sequential, alternating (22 patients) or concurrent (29 patients) regional PV FUDR and systemic fluorouracil (FU) with leucovorin chemotherapy. RESULTS: Fifty percent of patients were male. The mean age at diagnosis was 57 years. The mean number of lesions resected was three (range, one to 11 lesions). The stage at diagnosis was II, III, and IV in 16.9%, 52.8%, and 28.3% of patients, respectively. One- and 3-year overall survival rates were 92.7% and 41.8%, respectively. The 1- and 3-year disease-free survival rates were 64.5% and 19%, respectively. The site of first recurrence was hepatic in 35.9% of patients. Treatment was terminated early in 24 patients (17 patients progressed, two refused treatment, and five had nonhepatic toxicities). Fifty-five percent of patients received 75% to 100% of the planned FUDR courses, and 72% received greater than 50% of the planned FUDR dose. Only four patients required dose reductions of FUDR because of grade 3 hepatic toxicity. No patient required biliary stenting or had discontinuation of PV infusion because of hepatic toxicity. CONCLUSION: The delivery of PV FUDR and FU with leucovorin can be performed with a high percentage of expected drug delivery and a low drug-induced hepatic toxicity rate, while achieving acceptable overall and disease-free survival.

Systematic postoperative radiologic follow-up in patients with non-small cell lung cancer for detecting second primary lung cancer in stage IA.

HYPOTHESIS: Systematic postoperative evaluation of patients with non-small cell lung cancer will identify treatable second primary lung cancer and local recurrences. DESIGN: Retrospective review from January 1, 1996, to December 31, 2000. The follow-up protocol included an annual computed tomographic examination of the chest with interval chest radiography every 4 months for 2 years and every 6 months for 3 additional years. SETTING: A National Cancer Institute-designated comprehensive cancer center. PATIENTS: One hundred twenty-four patients with resected non-small cell lung cancer. MAIN OUTCOME MEASURES: Number and size of second primary and locally recurrent tumors, secondary surgical procedures, and survival of patients who underwent resection. RESULTS: The median diameter of resected second primary tumors detected by computed tomography was 14 mm (range, 8-28 mm) and by chest radiography was 26.5 mm (range, 23.0-35.0 mm) (P<.001). Of 14 patients with second primary lung cancer treated surgically, 9 were without evidence of disease at a median of 20 months (range, 4-56 months), 2 were alive with disease at 13 and 37 months, 2 died of unrelated causes but without evidence of disease at 7 and 35 months, and 1 died intraoperatively of a cardiac arrhythmia. CONCLUSIONS: Systematic follow-up of non-small cell lung cancer, including annual computed tomography, detects second primary lung cancer in stage IA. Limited pulmonary resections are often feasible in these patients. Locally recurrent lung cancer is infrequently resectable.