Development and Feasibility Evaluation of Smart Cancer Care 2.0 Based on Patient-Reported Outcomes for Post-Discharge Management of Patients with Cancer.

Purpose: A "Smart Cancer Care" platform that integrates patient-reported outcomes (PROs) with management has been established in Korea. This study focused on improving health behaviors and connecting patients to welfare services by introducing and assessing the feasibility of "Smart Cancer Care 2.0," an enhanced version designed for monitoring complications post-cancer treatment. Materials and Methods: Smart Cancer Care 2.0 was developed by conducting a literature review and consulting with expert panels to identify symptoms or variables requiring monitoring and management guidelines based on the treatment type. Qualitative and quantitative surveys were conducted to assess the feasibility of the app and web system based on the experiences of patients with cancer and healthcare workers. Results: A total of 81 symptoms or variables (chemotherapy-, surgery-, radiotherapy-, rehabilitation-, and health management-related) were selected for management in Smart Cancer Care 2.0. PROs for these symptoms were basically categorized into three severity grades: (1) preventive management, (2) self-treatment, and (3) consultation with a healthcare worker or visit to a healthcare institution. The overall mean scores in the feasibility evaluation by patients and healthcare workers were 3.83 and 3.90 points, respectively, indicating high usefulness. Conclusion: Smart Cancer Care 2.0 leverages the existing ICT-based platform, Smart Cancer Care, and further includes health behaviors and welfare services. Smart Cancer Care 2.0 may play a crucial role in establishing a comprehensive post-discharge management system for patients with cancer as it provides suitable interventions based on patients' responses and allows the regularly collected PROs to be easily viewed for streamlined care.

Follow-up bone scan in breast cancer patients: what is the appropriate interpretation of purely rib uptake?

AIM: Although rib uptake is frequently detected in follow-up bone scans of breast cancer patients, few studies have assessed its clinical significance. PATIENTS AND METHODS: Among 1208 breast cancer patients who underwent a bone scan between 2011 and 2014, 157 patients presented with newly detected rib uptake at follow-up. Patients who had underlying bone metastases (n=8) or had simultaneous new uptake in sites other than the rib (n=13) were excluded. The patients enrolled finally were those who had purely rib uptakes. The location, intensity, and final diagnosis of the uptake were evaluated by nuclear medicine physicians. RESULTS: A total of 275 new instances of rib uptake were detected in follow-up bone scans of 136 patients. These were more frequently located on the ipsilateral side of the breast cancer (61.1%) and the anterior arc (65.1%), and they presented as moderate to intense (93.1%) uptakes. Among these, 265 lesions in 130 patients turned out to be benign fractures (96.4%), whereas only 10 lesions in six patients were metastases. The proportion of metastases was significantly higher if the uptake was linear or if the patient had recurrence. It was marginally higher if the uptake was located in the posterior arc. The proportion of metastases within the radiation field was significantly lower in patients with a history of irradiation. CONCLUSION: Newly detected purely rib uptake on a follow-up bone scan in patients who have been treated for breast cancer is mostly because of fractures and rarely signals metastasis. However, if the patient has disease recurrence, metastasis should strongly be suspected, particularly when uptake is linear or located in the posterior arc.

Prospective phase II trial of a combination of gemcitabine and UFT as first-line treatment in elderly patients with advanced non-small cell lung cancer.

BACKGROUND: The standard regimen in elderly patients with non-small-cell lung cancer (NSCLC) is still uncertain. Gemcitabine is one of the most widely used drugs for the treatment of NSCLC, and several phase II trials specifically designed for elderly patients with advanced NSCLC have confirmed the role of gemcitabine in this setting. In addition, oral uracil-tegafur (UFT) was associated with a survival advantage in the adjuvant setting. Therefore, we performed a phase II study using the combination of gemcitabine and UFT as first-line therapy in elderly patients with advanced NSCLC. METHODS: Chemotherapy-naïve, elderly (≥ 70 years) patients who had histologically or cytologically confirmed with stage IIIB or IV NSCLC with a performance status of 1-2 were enrolled. Patients received gemcitabine (1250 mg/m(2) on days 1 and 8, respectively) and UFT (400mg/day on days 1-14) every 3 weeks for up to four cycles. Patients who had not progressed after four cycles continued UFT monotherapy until progression. Primary endpoint was overall response rate and secondary endpoints were overall survival, time to progression and safety profiles. RESULTS: Between March 2008 and November 2010, 48 patients were enrolled. The median age was 74.5 years (range: 70-84 years), and there were 29 males. The performance status was 1 in 41 and 2 in 7 patients. Thirty-one (64.6%) patients were stage IV and seventeen (35.4%) patients were stage IIIB. Thirty patients (62.5%) completed four cycles of chemotherapy. Response was evaluated in 44 patients. Partial response was achieved in twelve (25.0%) patients and stable disease in 23 (47.9%) patients. Disease control rate was 72.9%. The median survival time was 6.1 months (95% confidence interval [CI]; 5.1-7.0 months), the 1-year survival rate was 29.1% and the median time to progression was 4.6 months (95% CI; 3.7-5.5 months). Toxicities were mild and mostly hematological adverse events. Grade 3/4 neutropenia occurred in 8.3% of patients and one patients experienced febrile neutropenia. Grade 3/4 anemia and thrombocytopenia occurred in 2.1% and 2.1% of patients, respectively. Non-hematological toxicities were tolerable. CONCLUSIONS: The combination of gemcitabine and UFT was effective in disease control and well tolerated first-line regimen in elderly patients with advanced NSCLC.

Prospective phase II trial of a combination of fixed dose rate infusion of gemcitabine with cisplatin and UFT as a first-line treatment in patients with advanced non-small-cell lung carcinoma.

PURPOSE: The standard chemotherapy for non-elderly patients with advanced non-small-cell lung cancer (NSCLC) is platinum-based doublet combination therapy. Preclinical and clinical evidence indicates that infusion at the fixed dose rate (FDR) of 10mg/(m(2)min) may be more effective than a standard 30-min infusion of gemcitabine. In addition, oral uracil-tegafur (UFT) was associated with a survival advantage in the adjuvant setting. Therefore, we performed a phase II study using the combination of gemcitabine, cisplatin and UFT as first-line therapy in patients with advanced NSCLC. PATIENTS AND METHODS: Eligible patients had histologically or cytologically confirmed stage IIIB or IV NSCLC with a performance status of 0-2 and were chemotherapy-naive. Gemcitabine (1,250 mg/m(2), 10mg/(m(2)min) on days 1 and 8, respectively) and cisplatin (75 mg/m(2) on day 1) were injected intravenously and UFT (400mg/day) was administered orally on days 1-14. Treatment was repeated every 3 weeks for up to six cycles. Primary endpoint was overall response rate and secondary endpoints were overall survival, time to progression and safety profile. RESULT: Thirty-seven patients were enrolled. The median age was 60 years (range: 44-72 years). The performance status was 0 in 4, 1 in 30, and 2 in 3 patients. Twenty-three patients completed six cycles. Complete response was achieved in one (3%) patient, partial response in 17 (46%) patients, and stable disease in 10 (27%) patients. The overall response rate was 48.6% on an intention-to-treat basis and 54.5% of patients in whom a response evaluation was possible (n=33). The median survival time was 14.7 months (95% confidence interval [CI] 11.2-18.2), the 1-year survival rate was 54% and the median time to progression was 5.4 months (95% CI 4.3-6.4). Toxicities were moderate and mostly hematological adverse events. Grade 3/4 neutropenia occurred in 37% of patients and four patients experienced febrile neutropenia. Grade 3/4 anemia and thrombocytopenia occurred in 19% and 5% of patients, respectively. Non-hematological toxicities were mild. CONCLUSION: The combination of gemcitabine, cisplatin and UFT is an active and well-tolerated first-line regimen in patients with advanced NSCLC.

Optimal timing for the administration of capecitabine with preoperative chemoradiation for locally advanced rectal cancer.

PURPOSE: Capecitabine is an oral fluoropyrimidine carbamate and it is known as an effective radiosensitizer. Capecitabine and its metabolite reach their peak concentration in the plasma at 1 approximately 2 hours after a single oral administration of capecitabine and the levels fall rapidly thereafter. To verify the radiosensitizing effect of capecitabine that is based on such pharmacokinetic characteristics, we performed a retrospective analysis on the optimal timing of capecitabine administration with performing preoperative chemoradiation for locally advanced rectal cancer. MATERIALS AND METHODS: Among 171 patients who were treated with preoperative radiotherapy and concurrent capecitabine administration for rectal cancer, 56 patients were administered capecitabine at 1~2 hours before radiotherapy (group A), and at other time in the other 115 patients (group B). Total mesorectal excision was done at 4 to 6 weeks after the completion of chemoradiation. The radiosensitizing effect of capecitabine was evaluated on the basis of the pathological response. RESULTS: Complete pathological regression of the primary tumor was observed in 12 patients (21.4%) for group A and in 11 patients (9.6%) for group B (p=0.031). Residual disease less than 0.5 cm (a good response) was observed in 19 patients (33.9%) for group A and in 23 patients (20.0%) for group B (p=0.038). On multivariate analysis, the capecitabine ingestion time showed marginal significance. CONCLUSION: When performing preoperative chemoradiation for locally advanced rectal cancer, the radiosensitizing effect of capecitabine was enhanced when it was administered 1 hour before radiotherapy.

A less intensive combination of paclitaxel and carboplatin in advanced non-small cell lung cancer patients who have aged 60 years or more and has a poor performance status.

BACKGROUND: The aim of this study was to evaluate the response, survival, and toxicities of a less intensive combination of paclitaxel and carboplatin, which is used in advanced non-small cell lung cancer (NSCLC) patients older than 60 years of age including those with a poor performance status. METHODS: Thirty patients received 135 mg/m2 of paclitaxel on day 1, and carboplatin was administered to the patients on day 1 every 4 weeks over an area under the concentration-time curve of 6. RESULTS: The response rate was 40%, the median overall survival was 9.1 months (95% CI, 4.2 to 14 months), and the 1 year survival rate was 31%. The median progression-free survival was 7.7 months (95% CI, 3.1 to 12.2 months). In addition, the toxicities were generally mild and reversible. CONCLUSION: This study demonstrates that a less intensive combination of paclitaxel/carboplatin is active and well tolerated in advanced NSCLC patients who are older than 60 years including those with a poor PS 3-4.

Phase II study of three-dimensional conformal radiotherapy and concurrent mitomycin-C, vinblastine, and cisplatin chemotherapy for Stage III locally advanced, unresectable, non-small-cell lung cancer.

PURPOSE: To evaluate the feasibility, treatment outcome, and toxicity of hyperfractionated three-dimensional conformal radiotherapy (CRT) and concurrent mitomycin-C, vinblastine, and cisplatin (MVP) chemotherapy in locally advanced, unresectable, Stage III non-small-cell lung cancer (NSCLC). METHODS AND MATERIALS: Between August 1993 and December 1996, 161 patients with unresectable Stage III NSCLC were entered into this trial, and 146 (91%) completed the treatment. Hyperfractionated RT was given to a total dose of 64.8-70 Gy (1.2 Gy/fraction, b.i.d.) with two cycles of concurrent MVP chemotherapy (mitomycin-C 6 mg/m(2) on Days 2 and 29, vinblastine 6 mg/m(2) on Days 2 and 29, and cisplatin 60 mg/m(2) on Days 1 and 28). Of the 146 patients who completed the treatment, 78 received noncoplanar three-dimensional CRT using 4-6 fields and 17 received coplanar-segmented CRT. The clinical tumor response was assessed 1 month after RT completion by CT. Toxicity was graded using the Southwestern Oncology Group criteria. The normal tissue complication probability for the lung was calculated to determine the correlation with radiation pneumonitis, if any. Nineteen (13%) had Stage IIIA and 127 (87%) had IIIB disease, including 16 patients with pleural effusion and 20 with supraclavicular lymph node metastasis. RESULTS: The response rate was 75%, composed of 22% complete responders and 53% partial responders. With a minimal follow-up of 45 months, the overall survival rate was 51.2% at 1 year, 25.1% at 2 years, and 14.8% at 5 years; the median survival was 12 months. Patients achieving a complete response (n = 32) had a 2-year overall survival rate of 49.8% and a 5-year survival rate of 39.2% compared with 22.5% and 11.4%, respectively, for the partial responders (n = 78; p = 0.0001). The actuarial local progression-free survival rate for all patients was 65.4% at 1 year, 42.1% at 2 years, and 36.3% at 4 years, and the actuarial distant-free survival rate was 65.4% at 1 year, 42.1% at 2 years, and 36.2% at 5 years. Severe weight loss (>10%) occurred in 20 (13.7%) of the 146 patients during treatment, 42 patients (29%) developed radiation pneumonitis (29 Grade 1 and 13 Grade 2). The average normal tissue complication probability value of the patients who had radiation pneumonitis was significantly greater than that of patients without pneumonitis (66.0% vs. 26.4%). Four patients died of treatment-related toxicity. CONCLUSION: Hyperfractionated three-dimensional CRT and concurrent chemotherapy, as described here, is a well-tolerated regimen with acceptable toxicity. More effective treatment schemes are required to improve local disease control and overall survival.

Preliminary Results of Paclitaxel, Cisplatin and Concurrent High-Dose Radiation Therapy for Locally Advanced Non-Small-Cell Lung Cancer.

PURPOSE: To investigate the feasibility, toxicity and response rate, of concurrent chemoradiation therapy with paclitaxel/cisplatin in stage III locally advanced non-small cell lung cancer (NSCLC). MATERIALS AND METHODS: Between May 1999 and December 2000, 80 patients with stage III NSCLC were enrolled in a prospective protocol. Radiotherapy was given to a total dose of 70.2 Gy (daily fraction of 1.8 Gy for 5 days), over an 8 week period, on the gross tumor volume, combined with chemotherapy. The concurrent chemotherapy consisted of paclitaxel (40 mg/m2) and 20 mg/m2 cisplatin per week for 8 consecutive weeks. All patients received 3-D conformal radiotherapy using CT-simulated planning. Acute toxicities were evaluated by the RTOG scale. The median follow-up period was 16 months, ranging from 3 to 29 months. RESULTS: Of the 80 patients, 71 received treatment per protocol, with minor variation of protocol delivery. The median age of the patients was 60 years. Karnofsky Performance status were 100 and 90 in 62 patients, and 80 and 70 in 9, respectively. Weight loss of less than 5% for 6 months was observed in 22 patients. The response to treatment was evaluated from the radiological findings. Complete and partial responses were observed in 8 and 51 patients, respectively. Ultimately, 82% of patients (included complete responses: 8 cases) obtained more than a partial response. Although, radiation induced esophagitis was the most common treatment related toxicity, occurring in 44 patients (69%), severe radiation esophagitis like, grade 3, was observed in only 3 patients, and the most acute toxicities had completely recovered 1 month following treatment. The overall 2-year actuarial and progression free survivals were 56 and 45%, respectively. CONCLUSION: This combined modality has activity with manageable toxicity and 23 months in mean survival time in patients with stage III NSCLC. A longer follow up will be required to realise the expected higher survival of these results.

Ependymoma: a Retrospective Analysis of 25 Cases.

PURPOSE: We evaluated the patterns of failure, survival rate, prognostic factors and treatment related complication in postoperative radiation treatment of patients with ependymoma. MATERIALS AND METHODS: We retrospectively analyzed 25 patients with histologically confirmed ependymoma treated between Jun. 1990 and Jun. 2001 with postoperative radiotherapy at Asan Medical Center. The study group comprised of 16 men and 9 women, with a median age of 23 years; including 6 supratentorial, 15 infratentorial and 4 spinal cord lesions. The extents of resection were ranked as either: gross total, near total, subtotal, partial resection or biopsy, with these types of surgical resection being performed in 13, 3, 6, 1 and 2 patients, respectively. Twelve of the patients had low grade ependymoma, and the other 13 a high grade tumor. The postoperative irradiation was administered using 4 MV or 6 MV photons, up to median dose of 55.0 Gy (range, 45.0~59.4 Gy), with the radiation field encompassing the preoperative tumor volume plus a 2 cm margin. Only 8 of the patients received either pre- or postoperative chemotherapy. The median follow-up period of survivors was 43 months. RESULTS: Ten of the 25 patients (40%) developed a recurrence, and 5 died. Of the 10 recurred patients, 6 showed an in-field recurrence, and one developed both an in-field and an out of field recurrence. The remaining 3 patients showed an out of field recurrence, including one case with a leptomeningeal recurrence. The 5-year overall survival, and progression-free, survival rates were 74.0 and 56.1%, respectively. The histological grades were statistically significant prognostic factors of the overall and progression-free survival rates. There were no significant treatment related complications, with the exception of one case of panhypopituitarism, which occurred 30 months after completion of the radiotherapy. CONCLUSION: The main pattern of recurrence was due to local failure. In order to improve the local control, and to reduce complications, advanced radiation treatment techniques, such as 3 dimensional radiotherapy, may be needed.