Efficacy of the granisetron transdermal system for the control of nausea and vomiting induced by highly emetogenic chemotherapy: a multicenter, randomized, controlled trial

Background/Aims@#We compared the efficacy of the granisetron transdermal system (GTS) with that of ondansetron for controlling chemotherapy-induced nausea and vomiting (CINV) in patients treated with highly emetogenic chemotherapy (HEC). @*Methods@#We randomized a total of 389 patients to groups treated by GTS and ondansetron before HEC. The primary endpoint was the percentage of patients achieving complete response (CR; no retching/vomiting/rescue medication) of CINV from the time of chemotherapy initiation to 24 hours after the last administration of chemotherapy (prespecified non-inferiority margin of 15%). Quality of life (QoL) was also assessed using the Functional Living Index-Emesis (FLIE). @*Results@#The per protocol analysis included 152 (47.80%) and 166 patients (52.20%) in the GTS and ondansetron groups, respectively. In the full analysis set, the most common diagnosis, regimen, and period of chemotherapy were lung cancer (149 patients, 40.27%), cisplatin-based regimen (297 patients, 80.27%), and 1 day chemotherapy (221 patients, 59.73%). The CR rates were 86.84% and 90.36% in the GTS and ondansetron groups, respectively; the treatment difference was −3.52% (95% confidence interval, −10.52 to 3.48) and met the primary endpoint, indicating that GTS was not inferior to ondansetron. Patient satisfaction, assessed on the FLIE, showed significantly higher scores in the GTS group compared to the ondansetron group (mean ± standard deviation, 1,547.38 ± 306.00 and 1,494.07 ± 312.05 mm, respectively; p = 0.0449). @*Conclusions@#GTS provided effective, safe, and well-tolerated control of CINV and improved the QoL in HEC.

In Memoriam: Waun Ki Hong, M.D. (August 13, 1942-January 2, 2019) / Journal of the Korean Cancer Association, 대한암학회지

No abstract available.

Randomized Phase III Trial of Irinotecan Plus Cisplatin versus Etoposide Plus Cisplatin in Chemotherapy-Naïve Korean Patients with Extensive-Disease Small Cell Lung Cancer / Journal of the Korean Cancer Association, 대한암학회지

PURPOSE: This randomized phase III study was designed to compare the efficacy and safety of irinotecan plus cisplatin (IP) over etoposide plus cisplatin (EP) in Korean patients with extensive-disease small-cell lung cancer (SCLC). MATERIALS AND METHODS: Patients were randomly assigned to receive IP, composed of irinotecan 65 mg/m2 intravenously on days 1 and 8+cisplatin 70 mg/m2 intravenously on day 1 every 3 weeks, or EP, composed of etoposide 100 mg/m2 intravenously on days 1, 2, 3+cisplatin 70 mg/m2 intravenously on day 1, every 3 weeks for a maximum of six cycles, until disease progression, or until unacceptable toxicity occurred. The primary endpoint was overall survival. RESULTS: A total of 362 patients were randomized to IP (n=173) and EP (n=189) arms. There were no significant differences between IP and EP arms for the median overall survival (10.9 months vs. 10.3 months, p=0.120) and the median progression-free survival (6.5 months vs. 5.8 months, p=0.115). However, there was a significant difference in response rate (62.4% vs. 48.2%, p=0.006). The pre-planned subgroup analyses showed that IP was associated with longer overall survival in male (11.3 months vs. 10.1 months, p=0.036), < 65 years old (12.7 months vs. 11.3 months, p=0.024), and Eastern Cooperative Oncology Group performance status 0/1 (12.4 months vs. 10.9 months, p=0.040) patient groups. The severity of treatment-related adverse events such as grade 3/4 anemia, nausea and diarrhea was more frequent in patients treated with IP. CONCLUSION: The IP chemotherapy did not significantly improve the survival compared with EP chemotherapy in Korean patients with extensive-disease SCLC.

Adopting Advance Directives Reinforces Patient Participation in End-of-Life Care Discussion / Journal of the Korean Cancer Association, 대한암학회지

PURPOSE: In Korea, most terminal cancer patients have still not been included in end-of-life (EOL) discussions. The purpose of this study was to evaluate the proportion of patients participating in EOL discussions after adopting advance directives. MATERIALS AND METHODS: Medical records of 106 hospice patients between July 2012 and February 2013 were reviewed retrospectively. The proportion of patient participation in EOL discussions, barriers, and favorable factors for completion of advance directives, as well as outcomes of advance directives were evaluated. RESULTS: Patient participation in EOL discussion had increased from 16/53 (30%) to 27/53 (51%) since adopting advance directives (p < 0.001). Median time between completion of an advance directive and death increased from 8 days (range, 0 to 22 days) to 14.5 days (range, 0 to 47 days). Patients' poor condition after late referral was the main barrier to missing EOL discussions; however, family members' concerns about patient's distress was also a main reason for excluding the patient from EOL discussions. In univariate analysis, patient age, education status, and time from diagnosis to completion of an advance directive influenced advance directive completion favorably. Following multivariate analysis, higher education and periods of more than 2 years from diagnosis to completion of an advance directive remained favorable (odds ratio [OR], 9.586, p=0.024 and OR, 70.312; p=0.002). Preferences of all patients regarding cardiopulmonary resuscitation or hemodialysis were carried out by physicians. Orders for nutrition and palliative sedation showed discordance, with concordance rates of 74.2% and 51.6%, respectively. CONCLUSION: Our results suggested that the use of advance directive promote patient participation in EOL discussion.

A Case of Small Cell Carcinoma of the Maxillary Sinus with Distant Metastasis / 대한내과학회지

Primary small cell carcinoma of the paranasal sinuses is extremely rare. It is aggressively locally invasive, with high recurrence and metastatic rates. A combination of systemic chemotherapy and locoregional treatment, such as radiotherapy, is currently recommended based on the treatment of small cell carcinoma of lung. We report a case of small cell carcinoma originating from the maxillary sinus with distant metastasis at the time of diagnosis. The patient had a good initial therapeutic response to etoposide-cisplatin chemotherapy, but the cancer progressed after the sixth cycle of chemotherapy and the prognosis was poor.

The Efficacy of External Beam Radiotherapy for Airway Obstruction in Lung Cancer Patients / Journal of the Korean Cancer Association, 대한암학회지

PURPOSE: The objective of this study was to evaluate external beam radiotherapy (EBRT) in lung cancer patients who suffer from airway obstruction. MATERIALS AND METHODS: Medical data of 95 patients with a lung mass that obstructed the airway and received EBRT for it were analyzed. Fifty-nine patients (62.1%) had non-small cell lung cancer and 36 patients (37.9%) had small cell lung cancer. Radiotherapy was given at 8 to 45 Gy (median, 30 Gy) in 1 to 15 fractions (median, 10 fractions). The response to EBRT was assessed through changes in radiographic findings and/or subjective symptoms between before and after EBRT. The median follow-up duration was 124 days. The primary end point was the airway-obstruction resolving rate after EBRT. The secondary end points were patient survival and toxic effects of EBRT. RESULTS: Improvement of airway obstruction after EBRT on chest X-ray was achieved in 75 of 95 patients (78.9%). The median time for resolving the radiologic findings and/or symptoms of airway obstruction after EBRT was 7 days (range, 1 to 76 days). The 1-year survival rate was significantly higher in responders than non-responders (12.5% vs. 0.0%, p or = 39 Gyalpha/beta=10 (p < 0.01) and the longest obstructive lesion of < 6 cm (p=0.04) were significantly associated with a good response to EBRT in resolving the airway obstruction. No one had grade 3 or higher acute and chronic toxicities. CONCLUSION: EBRT is an effective treatment in relieving airway obstruction without severe toxicities in lung cancer patients.

Experience of Advance Directives in a Hospice Center

To protect patient autonomy when confronting death, the importance of advance directives (ADs) has recently became an issue and gradually accepted in Korea. However, in real practice, ADs were not completed by patients but their families in most cases. To analyze the current situation of performing ADs, we reviewed medical charts of 214 terminal cancer patients admitted to the hospice center from October 2012 to September 2013. Seventy-six (35.5%) patients completed ADs. All ADs were completed by patients themselves. The most common reason for not completing ADs was poor physical and/or mental condition. As a proxy, the majority of patients preferred their spouses (55.3%). Few patients wanted life sustaining treatment (1.3%), however palliative sedation was accepted in 89.5%. The median timing of ADs after admission was three (0-90) days, and duration of survival since ADs was 22 (1-340) days. In conclusion, approximately one third of terminal cancer patients completed ADs by themselves. Considering that patient's poor condition is the main reason for not completing ADs, earlier discussion regarding ADs is necessary to enhance patients' participation.

Experience of Advance Directives in a Hospice Center

To protect patient autonomy when confronting death, the importance of advance directives (ADs) has recently became an issue and gradually accepted in Korea. However, in real practice, ADs were not completed by patients but their families in most cases. To analyze the current situation of performing ADs, we reviewed medical charts of 214 terminal cancer patients admitted to the hospice center from October 2012 to September 2013. Seventy-six (35.5%) patients completed ADs. All ADs were completed by patients themselves. The most common reason for not completing ADs was poor physical and/or mental condition. As a proxy, the majority of patients preferred their spouses (55.3%). Few patients wanted life sustaining treatment (1.3%), however palliative sedation was accepted in 89.5%. The median timing of ADs after admission was three (0-90) days, and duration of survival since ADs was 22 (1-340) days. In conclusion, approximately one third of terminal cancer patients completed ADs by themselves. Considering that patient's poor condition is the main reason for not completing ADs, earlier discussion regarding ADs is necessary to enhance patients' participation.

Identification of EGFR Mutations by Immunohistochemistry with EGFR Mutation-Specific Antibodies in Biopsy and Resection Specimens from Pulmonary Adenocarcinoma / Journal of the Korean Cancer Association, 대한암학회지

PURPOSE: Mutation-specific antibodies have recently been developed for identification of epidermal growth factor receptor (EGFR) mutations by immunohistochemistry (IHC). This study was designed to investigate whether the type of specimen (biopsy vs. resection) would make a difference in determining mutation status by IHC, and to evaluate whether biopsies are suitable for detection of mutant EGFR protein. MATERIALS AND METHODS: IHC was performed using mutation-specific antibodies for E746-A750 deletion (DEL) and L858R point mutation (L858R) in biopsies and tissue microarrays of resected tumors from 154 patients with pulmonary adenocarcinoma. Results were then compared with DNA sequencing data. RESULTS: Molecular-based assays detected EGFR mutations in 62 patients (40.3%), including 14 (9.1%) with DEL, and 31 (20.1%) with L858R. IHC with two mutation-specific antibodies showed a homogeneous staining pattern, and correctly identified EGFR mutation status in 89% (137/154). Overall (biopsy/resection) sensitivity, specificity, positive predictive value, and negative predictive value were 75.6% (78.3%/72.7%), 94.5% (90.9%/96.3%), 85% (78.3%/88.9%), and 90.4% (90.9%/89.7%), respectively. CONCLUSION: Our data showed that IHC using EGFR mutation-specific antibodies is useful for detection of EGFR mutations with high specificity and good sensitivity not only for resection specimens but also for biopsy materials. Therefore, IHC using EGFR mutation-specific antibodies may preclude a second biopsy procedure to obtain additional tissues for identification of EGFR mutations by molecular assays in biopsies from advanced cancer, particularly when tumor cells in the samples are limited.

A Randomized Double-Blind, Double-Dummy, Multicenter Trial of Azasetron versus Ondansetron to Evaluate Efficacy and Safety in the Prevention of Delayed Nausea and Vomiting Induced by Chemotherapy / Journal of the Korean Cancer Association, 대한암학회지

PURPOSE: This study was conducted to evaluate the efficacy and safety of azasetron compared to ondansetron in the prevention of delayed chemotherapy-induced nausea and vomiting. MATERIALS AND METHODS: This study was a multi-center, prospective, randomized, double-dummy, double-blind and parallel-group trial involving 12 institutions in Korea between May 2005 and December 2005. A total of 265 patients with moderately and highly emetogenic chemotherapy were included and randomly assigned to either the azasetron or ondansetron group. All patients received azasetron (10 mg intravenously) and dexamethasone (20 mg intravenously) on day 1 and dexamethasone (4 mg orally every 12 hours) on days 2-4. The azasetron group received azasetron (10 mg orally) with placebo of ondansetron (orally every 12 hours), and the ondansetron group received ondansetron (8 mg orally every 12 hours) with placebo of azasetron (orally) on days 2-6. RESULTS: Over days 2-6, the effective ratio of complete response in the azasetron and ondansetron groups was 45% and 54.5%, respectively (95% confidence interval, -21.4 to 2.5%). Thus, the non-inferiority of azasetron compared with ondansetron in delayed chemotherapy-induced nausea and vomiting was not proven in the present study. All treatments were well tolerated and no unexpected drug-related adverse events were reported. The most common adverse events related to the treatment were constipation and hiccups, and there were no differences in the overall incidence of adverse events. CONCLUSION: In the present study, azasetron showed inferiority in the control of delayed chemotherapy-induced nausea and vomiting compared with ondansetron whereas safety profiles were similar between the two groups.

Secondary Prophylaxis of Docetaxel Induced Diarrhea with Loperamide: Case Report

Diarrhea is a common adverse event of docetaxel with 20%-40% of incidence and severe diarrhea occurs in 5%-6%. Several treatment guidelines for chemotherapy induced diarrhea (CID) exist, however the prophylaxis for that is not well known. We describe a new prophylactic approach for the CID with loperamide. A 72-yr-old male patient with stage IV non-small-cell lung cancer developed diarrhea repeatedly after docetaxel-cisplatin chemotherapy. His diarrhea persisted despite treatment including loperamide and fasting. However, the diarrhea was successfully prevented when loperamide was given before and after the chemotherapy. To our knowledge, this is the first report of prophylactic approach for the CID with loperamide.

Intussusception Induced by Cecal Metastasis of Primary Small Cell Lung Cancer / 대한내과학회지

Large bowel metastasis from a primary lung cancer is rare and is hard to be asymptomatic. We report a case of intussusception without any symptoms caused by cecal metastasis of primary small cell lung cancer. A 70-year-old woman was admitted to hospital with cough and sputum of 3 weeks' duration. She was diagnosed with small cell lung cancer based on percutaneous needle biopsy of a lung mass identified by chest CT. In abdominal CT, multiple metastatic lesions were detected in the left adrenal gland and cecum with intussusception. After further colonoscopy and biopsy evaluations, the pathology results showed metastatic cancer originating from small cell cancer of the lung.

Three Cases of Cough Syncope in Lung Cancer Patients / 결핵및호흡기질환

Cough syncope is characterized by the loss of consciousness occurring after vigorous coughings. There are approximately 90 reported cases of cough syncope within the medical literature. Most cases involving middle aged, overweight and chronic bronchitic male smokers. Although many studies have been published in the medical literature, the mechanism and pathophysiology for cough syncope has not been well established. Cough syncope is treated by correcting the underlying cause when identified, or by avoiding conditions that may cause the cough syncope. In addition, cough suppression modalities can also be used. We herein report 3 cases of cough syncope presenting in lung cancer patients.

Efficacy of Epidural Analgesia in Patients with Cancer Pain: A Retrospective Observational Study

PURPOSE: Pain in terminal cancer patients may be refractory to systemic analgesics or associated with adverse drug reactions to analgesics. Epidural analgesia has been effectively used in such patients for pain control. However, this method does not provide pain relief to all patients. The efficacy and complications of continuous epidural analgesia were evaluated for expanding efficacy in terminal cancer patients. MATERIALS AND METHODS: The charts of patients who received epidural analgesia for over 5 years for the control of terminal cancer pain were reviewed retrospectively. RESULTS: Ninety-six patients received 127 epidural catheters. The mean duration for epidural catheterization was 31.5+/-55.6 (5-509) days. The dose of epidural morphine increased by 3.5% per day. The efficacy of epidural analgesia at 2 weeks follow up revealed improved pain control (n=56), as the morphine equivalent drug dose dropped from 213.4 mg/day to 94.1 mg/day (p<0.05) at 2 weeks follow up. Accordingly, after 2 weeks institution of epidural analgesia, there was a significant reduction in the proportion of patients with severe pain, from 78.1% to 19.6% (p<0.05). CONCLUSION: Epidural analgesia was an effective pain control method in patients with terminal cancer pain, however, a systematized algorithm for the control of cancer-related pain in needed.

A Case of Renal Angiomyolipoma with Lymph Node-Associated Elevation of Tumor Markers / 대한내과학회지

Angiomyolipoma is a rare, benign, mesenchymal hamartomatous neoplasm consisting of a mixture of adipose tissue, smooth muscle cells, and anomalous blood vessels. The kidney is a common origin site, but extrarenal angiomyolipoma has been reported. Simultaneous involvement of the kidney and regional lymph nodes is uncommon, and may be confused with a metastatic malignant lymph node. Lymph node involvement in angiomyolipoma represents a multifocal invasion of the tumor, rather than metastatic disease. Tumor markers usually associate with malignancy but they have sometimes been detected in benign conditions. We report a case of bilateral renal angiomyolipoma with tuberous sclerosis simultaneously involving regional lymph nodes confused with metastatic malignant lymph node enlargement due to associated elevation of serum tumor markers.

Gemcitabine Plus Platinum Combination Chemotherapy for Elderly Patients with Advanced Non-small Cell Lung Cancer: A Retrospective Analysis / Journal of the Korean Cancer Association, 대한암학회지

PURPOSE: This study aimed to analyze the efficacy and toxicity of gemcitabine plus platinum chemotherapy for patients aged 70 years or older with advanced non-small-cell lung cancer (NSCLC). MATERIALS AND METHODS: We reviewed the records of stage IIIB, IV NSCLC patients or surgically inoperable stage II, IIIA NSCLC patients who were aged 70 years or older when treated with gemcitabine (1,250 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC5) chemotherapy from 2001 to 2010 at Seoul St. Mary's Hospital, Uijeongbu St. Mary's Hospital and St. Vincent's Hospital. Gemcitabine was administered on days 1 and 8, and cisplatin or carboplatin was administered on day 1. Treatments were repeated every 3 weeks for a maximum of 4 cycles. RESULTS: The median age of the 62 patients was 73.5 years (range, 70 to 84 years). Forty-one (66%) patients exhibited comorbidity. The mean number of treatment cycles was 3.9. The compared average relative dose intensity of gemcitabine plus platinum chemotherapy was 84.8%. The median progression-free survival and overall survival (OS) were 5.0 months and 9.4 months, respectively. Reduced Eastern Cooperative Oncology Group (ECOG) performance status (none vs. > or =1) and weight loss ( or =5%) after treatment were found to have a significant effect on OS (p=0.01). CONCLUSION: Gemcitabine plus platinum chemotherapy is an effective treatment option with an acceptable level of toxicity in patients aged 70 years or older with good performance status in advanced NSCLC.

Prognostic Role of Rb, p16, Cyclin D1 Proteins in Soft Tissue Sarcomas / Journal of the Korean Cancer Association, 대한암학회지

PURPOSE: The aim of this study was to determine the expressions of Rb, p16, and cyclin D1 in soft tissue sarcomas, and we also wanted to identify the prognostic factors according to the clinicalpathologic features. MATERIALS AND METHODS: We reviewed the charts and radiographic films of 66 sarcoma patients. Tissue samples were collected from these patients. Immunochemistry was performed using formalin-fixed, paraffin-embedded tissue samples to examine the expressions of p16, Rb, and cyclin D1 proteins. RESULTS: The median duration of overall survival was 47.8 months (range, 20.0 to 70.7 months) and the 5 years survival rate was 39%. As for the correlation between the degree of immunohistochemical staining for Rb protein and the histological tumor grades, there was a significant difference with a p-value of 0.019. However, no significant correlation was shown for p16 and cyclin D1. The overall survival duration of the Rb negative group (staining cell <20%) and the heterogeneous group (cell staining 20 to 80%) was 53.5+/-6.6 months and the overall survival duration of the Rb homogeneous group was 18.3+/-6.4 months, and there was a significant difference with a p-value of 0.016. However, no significant difference was shown between the survival rate according to the p16 and cyclin D1 expressions. On the multivariate analysis that was done with Rb, p16, the tumor size, grade and site, and patient age, the Rb gene expression was the most significant independent prognostic factor with a risk ratio of 3.01 (p=0.04). CONCLUSION: The expression of Rb protein was correlated with the histologic grade and overall survival of patients with soft tissue sarcomas.

Predictors of Axillary Lymph Node Metastases (ALNM) in a Korean Population with T1-2 Breast Carcinoma: Triple Negative Breast Cancer has a High Incidence of ALNM Irrespective of the Tumor Size / Journal of the Korean Cancer Association, 대한암학회지

PURPOSE: We estimated the likelihood of breast cancer patients having axillary lymph node metastases (ALNM) based on a variety of clinical and pathologic factors. MATERIALS AND METHODS: Three hundred sixty-one breast cancer patients without distant metastases and who underwent breast conserving surgery and axillary lymph node dissection (ALND) (level I and II) or modified radical mastectomy (MRM) were identified, and we retrospectively reviewed their pathology records and treatment charts. RESULTS: Positive axillary lymph nodes were detected in 104 patients for an overall incidence of 28.8%: 2 patients (5%) with T1a tumor, 5 (9.2%) with T1b tumor, 24 (21.8%) with T1c tumor and 73 (44.2%) with T2 tumor. On the multivariate analysis, an increased tumor size (adjusted OR=11.87, p=0.02), the presence of lymphovascular invasion (adjusted OR=7.41, p<0.01), a triple negative profile (ER/PR-, Her2-) (adjusted OR=2.09, p=0.04) and a palpable mass at the time of diagnosis (adjusted OR=2.31, p=0.03) were all significant independent factors for positive ALNM. CONCLUSION: In our study, the tumor size, the presence of lymphovascular invasion, a triple negative profile and a palpable mass were the independent predictive factors for ALNM. The tumor size was the strongest predictor of ALNM. Thus, the exact estimation of the extent of tumor is necessary for clinicians to optimize the patients' care. Patients with a triple negative profile have a high incidence of ALNM irrespective of the tumor size.

Partial remission of a primary gastric choriocarcinoma after etoposide and cisplatin chemotherapy in a hemodialysis patient / 대한내과학회지

Primary gastric choriocarcinomas are rare and no treatment regimen for hemodialysis patients with a primary gastric choriocarcinoma has been established. We report a partial response to etoposide and cisplatin chemotherapy in a hemodialysis patient with a primary gastric choriocarcinoma. A 69-year-old woman with end-stage renal disease experienced hematemesis for 3 days. Gastroduodenoscopy revealed an ulcerative mass with recent bleeding. A subtotal Billroth II gastrectomy was performed and a gastric choriocarcinoma was identified histopathologically. One month postoperatively, recurrence was diagnosed by detecting an elevated serum beta-human chorionic gonadotropin (beta-HCG) level and multiple liver and lymph node metastases. The patient was treated with chemotherapy consisting of etoposide and cisplatin (EP). After six cycles of EP chemotherapy, the tumor size decreased markedly and a partial response was seen on computed tomography. Post-therapy positron emission tomography showed a complete metabolic response and the serum beta-HCG level had normalized.

Randomized, Multicenter, Phase III Trial of Heptaplatin 1-hour Infusion and 5-Fluorouracil Combination Chemotherapy Comparing with Cisplatin and 5-Fluorouracil Combination Chemotherapy in Patients with Advanced Gastric Cancer / Journal of the Korean Cancer Association, 대한암학회지

PURPOSE: Heptaplatin (Sunpla) is a cisplatin derivative. A phase IIb trial using heptaplatin resulted in a 34% response rate with mild nephrotoxicity. We conducted a randomized phase III trial of heptaplatin plus 5-FU compared with cisplatin plus 5-FU in patients with advanced gastric cancer. MATERIALS AND METHODS: One hundred seventy-four patients (heptaplatin, n=88; cisplatin, n=86) from 13 centers were enrolled. The eligibility criteria were as follows: patients with pathologically-proven adenocarcinoma, chemonaive patients, or patients who had received only single adjuvant chemotherapy, and who had a measurable or evaluable lesion. On day 1, heptaplatin (400 mg/m2) or cisplatin (60 mg/m2) was given over 1 hour with 5-FU (1 gm/m2) on days 1~5 every 4 weeks. RESULTS: At the time of survival analysis, the median overall survival was 7.3 months in the 5-FU + heptaplatin (FH) arm and 7.9 months in the 5-FU + cisplatin (FP) arm (p=0.24). Of the FH patients, 34.2% (complete response [CR], 1.3%; partial response [PR], 32.9%) experienced a confirmed objective response compared with 35.9% (CR 0%, PR 35.9%) of FP patients (p=0.78). The median-time-to-progression was 2.5 months in the FH arm and 2.3 months in the FP arm. The incidence of neutropenia was higher with FP (28%) than with FH (16%; p=0.06); grade 3~4 nausea and vomiting were more frequent in the FP than in the FH arm (p=0.01 and p=0.05, respectively). The incidence of increased proteinuria and creatininemia was higher with FH than with FP; however, there was no statistical difference. There were no treatment-related deaths. CONCLUSION: Heptaplatin showed similar effects to cisplatin when combined with 5-FU in advanced gastric cancer patients with tolerable toxicities.