Multi-Institutional Randomized Phase II Trial of Gefitinib for Previously Treated Patients With Advanced Non-Small-Cell Lung Cancer.

Purpose: To evaluate the efficacy and tolerability of two doses of gefitinib (Iressa [ZD1839]; AstraZeneca, Wilmington, DE), a novel epidermal growth factor receptor tyrosine kinase inhibitor, in patients with pretreated advanced non-small-cell lung cancer (NSCLC).

Patients And Methods: This was a randomized, double-blind, parallel-group, multicenter phase II trial. Two hundred ten patients with advanced NSCLC who were previously treated with one or two chemotherapy regimens (at least one containing platinum) were randomized to receive either 250-mg or 500-mg oral doses of gefitinib once daily.

Safety, tolerability, pharmacokinetics, and pharmacodynamics of the afucosylated, humanized anti-EPHA2 antibody DS-8895a: a first-in-human phase I dose escalation and dose expansion study in patients with advanced solid tumors.

Background: Erythropoietin-producing hepatocellular receptor A2 (EPHA2) is overexpressed on the cell surface in many cancers and predicts poor prognosis. DS-8895a is a humanized anti-EPHA2 IgG1 monoclonal antibody afucosylated to enhance antibody-dependent cellular cytotoxicity activity. We conducted a two-step, phase I, multicenter, open-label study to determine the safety, tolerability, and pharmacokinetics of DS-8895a in patients with advanced solid tumors.

The role of initial neck dissection for patients with node-positive oropharyngeal squamous cell carcinomas.

Background: The current study sought to assess the role of initial neck dissection (ND) for patients with node-positive oropharyngeal squamous cell carcinomas (OPSCC).

Methods: The data for 202 patients with previously untreated node-positive OPSCC were gathered from 12 institutions belonging to the Head and Neck Cancer Study Group in the Japan Clinical Oncology Group. These patients were categorized into two groups, consisting of the initial ND group and the wait-and-see group, according to treatment policy.

[Current problems for outpatients undergoing cancer chemotherapy in Ehime Priority Hospitals of Cancer Care Network (Ehime Cancer Kyoten Hospitals)].

Ehime Priority Hospitals of Cancer Care Network(Ehime Cancer Kyoten Hospitals)regularly have meetings to discus the current problems in cancer care in Ehime Prefecture. We established three subcommittees:"Registration of Cancer Incident," "Critical Paths for the Management of Patients with Cancer,"and"Palliative Care for Patients with Advanced Cancer"to exchange our opinions. We recently set up a new subcommittee related to the physical and spiritual care of patients undergoing chemotherapy treatment,"A Subcommittee dealing with Cancer Chemotherapy and its Management".

Two cases of occult breast cancer in which PET-CT was helpful in identifying primary tumors.

We report two cases of occult breast cancer in which masses were completely nonpalpable and positron emission tomography-computed tomography (PET-CT) was extremely helpful in identifying the primary tumor. Case 1 involved a 56-year-old woman with enlarged lymph nodes 3 cm in size in the axilla. Based on excisional biopsy, axillary lymph node metastasis of breast cancer was suspected but an obvious primary tumor in the breast was not identifiable on mammography, contrast-enhanced CT, or ultrasonography.

Epidermal inclusion cyst of the breast.

Epidermal inclusion cysts are uncommon in the breast, but the consequences can be severe when these cysts occur in the breast parenchyma. Here, we report two such cases. The patient in case 1 was an 85-year-old woman with a 3-cm palpable mass in the right breast.

Dofequidar fumarate (MS-209) in combination with cyclophosphamide, doxorubicin, and fluorouracil for patients with advanced or recurrent breast cancer.

Purpose: To evaluate the efficacy and tolerability of dofequidar plus cyclophosphamide, doxorubicin, and fluorouracil (CAF) therapy in comparison with CAF alone, in patients with advanced or recurrent breast cancer. Dofequidar is a novel, orally active quinoline derivative that reverses multidrug resistance.

Patients And Methods: In this randomized, double-blind, placebo-controlled trial, patients were treated with six cycles of CAF therapy: 28 days/cycle, with doxorubicin (25 mg/m2) and fluorouracil (500 mg/m2) administered on days 1 and 8 and cyclophosphamide (100 mg orally [PO]) administered on day 1 through 14.

S-1 (TS-1) maintained complete response for approximately 10 years in a case of metastatic breast cancer.

We present a patient with pulmonary metastasis from breast cancer who received S-1 (TS-1) and maintained complete response for approximately 10 years after recurrence. A 51-year-old woman underwent modified radical mastectomy for left breast cancer in November 1991. Her cancer was postoperatively classified as pT2 pN0 M0 Stage IIA.

Efficacy and toxicity of vinorelbine with doxorubicin/cyclophosphamide combination chemotherapy in a phase I-II study for advanced or recurrent breast cancer patients.

Background: To evaluate the efficacy and toxicity of vinorelbine (VNB) with doxorubicin/cyclophosphamide (AC) combination chemotherapy, a phase I-II study was carried out in patients with advanced or recurrent breast cancer.

Methods: The phase I part of this study was carried out to determine the treatment schedule and acceptable dose of VNB for the phase II study. In phase I, VNB was initially given as a short infusion on days 1, 8 and 15, every 4 weeks.

An in situ carcinoma of the pancreas forming 2 invasive ductal carcinomas.

A 62-year-old man underwent distal pancreatectomy for invasive pancreatic carcinoma. Histopathologically, the main lesion that obstructed the main pancreatic duct and measured 2.0 cm in diameter was a moderately differentiated adenocarcinoma with marked neural invasion.

Identification of serum proteins related to adverse effects induced by docetaxel infusion from protein expression profiles of serum using SELDI ProteinChip system.

Background: For the development of quick and easy methods for screening and identifying treatment-responsive proteins, we determined the protein expression profile of the serum after docetaxel infusion using a surface-enhanced laser desorption/ionization time-of-flight mass spectroscopy (SELDI TOF-MS) system.

Materials And Methods: Blood from breast cancer patients was collected before and 4, 8, 24 and 48 hours after docetaxel infusion. The protein expression profile was determined by a SELDI TOF-MS system.

Progressive central nervous system metastases in responder patients for outside central nervous system metastases on trastuzumab-based therapy--report of two cases of refractory breast cancer.

We report two cases of central nervous system (CNS) metastases during systemic response to trastuzumab in combination with chemotherapy for refractory breast cancer. The patients responded to trastuzumab in combination with chemotherapy. During combination treatment, the patients developed cerebellar metastases.

A phase I study of doxifluridine combined with weekly paclitaxel for metastatic gastric cancer.

Purpose: Based on the synergistic effect in preclinical studies, a phase I clinical trial for the combination of paclitaxel and doxifluridine (an intermetabolite of capecitabine) was performed to determine the recommended dose for the treatment of patients with metastatic gastric cancer.

Methods: The dose of paclitaxel was increased from 60 mg/m2 at level 1 to 90 mg/m2 at level 5. It was administered as a 1-h infusion on days 1 and 8.

Nationwide survey on complementary and alternative medicine in cancer patients in Japan.

Purpose: To determine the prevalence of use of complementary and alternative medicine (CAM) by patients with cancer in Japan, and to compare the characteristics of CAM users and CAM nonusers.

Patients And Methods: A questionnaire on cancer CAM and the Hospital Anxiety and Depression Scale were delivered to 6,607 patients who were treated in 16 cancer centers and 40 palliative care units.

Results: There were 3,461 available replies for a response rate of 52.

Multiple ground-glass opacity in metastasis of malignant melanoma diagnosed by lung biopsy.

Focal ground-glass opacity (GGO) on computed tomography has been reported in several disorders including inflammatory disease and primary neoplastic lesion of the lung. We report a case of malignant melanoma of the nasal cavity metastatic to the lungs in which multiple pulmonary nodules showed GGO. Lung biopsy specimen demonstrated melanoma cells proliferating in a lepidic fashion along the thickened alveolar wall simulating bronchioloalveolar carcinoma.

[The long-term results of hepatic resection for metastatic lesions from colorectal cancer].

We reviewed the clinical course of 51 patients who underwent hepatic resection for metastatic lesions from colorectal cancer between January 1984 and December 1997. The cumulative survival rate at 3 and 5 years were 57% and 43%, respectively. Sex, age, chronology of liver metastases (LM), number of LM, maximum diameter of LM, macroscopic surgical resection margin, type of hepatic resection, chemotherapy after hepatic resection, and site of primary tumor were not found to be statistically significant prognostic factors.

A phase II study of S-1 in patients with metastatic breast cancer--a Japanese trial by the S-1 Cooperative Study Group, Breast Cancer Working Group.

Background: S-1 is a newly developed novel oral dihydrouracil dehydrogenase inhibiting fluoropyrimidine drug consisting of 1 M tegafur (FT), 0.4 M 5-chloro-2, 4-dihydroxypyrimidine (gimeracil), and 1 M potassium oxonate (oteracil), with efficient antitumor activity and low gastrointestinal toxicity which is widely used in Japan against advanced gastric, head and neck cancers. We investigated its clinical efficacy against metastatic breast cancer.

Capecitabine plus docetaxel combination chemotherapy for metastatic breast cancer.

Doxifluridine(5'-DFUR)is converted to its metabolite 5-FU by the enzyme thymidine phosphorylase(TP). TP is expressed significantly higher in tumor tissue than in normal tissue. Capecitabine(N4-pentoxylcarbonyl -5'-deoxy-5-fluorocytidine)is a pro-drug of 5'-DFUR and a novel fluoropyrimidine carbamate that is converted to 5-FU preferentially in tumor tissue through a three-step enzymatic cascade.

Surgical treatments for multiple primary adenocarcinoma of the lung.

Background: The aim of this study was to identify the clinical characteristics of multiple primary adenocarcinomas and to evaluate the efficacy of surgical treatments.

Methods: Three-hundred sixty-nine patients who underwent pulmonary resection for adenocarcinoma from January 1994 to December 2002 were reviewed.

Results: Thirty-one patients (8.

Phase I and pharmacokinetic study of KW-2170, a novel pyrazoloacridone compound, in patients with malignant tumors.

Purpose: The primary purposes of this study were to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD), to recommend a dose for phase II studies, and to analyze the pharmacokinetics of KW-2170. A secondary purpose was to assess tumor response to KW-2170.

Experimental Design: KW-2170 was given as a 30-min i.

The ratio of thymidine phosphorylase to dihydropyrimidine dehydrogenase in tumour tissues of patients with metastatic gastric cancer is predictive of the clinical response to 5'-deoxy-5-fluorouridine.

The aim of this work was to determine whether intratumour contents of thymidine phosphorylase (TP), which converts 5'-deoxy-5-fluorouridine (5'-DFUR) to 5-fluorouracil, and dihydropyrimidine dehydrogenase (DPD), which degrades 5-fluorouracil to inactive molecules, could be useful in predicting the response of patients with metastatic gastric cancer to chemotherapy using 5'-DFUR. Endoscopic biopsy specimens for the measurement of TP and DPD were obtained from the primary lesions before the start of combination chemotherapy, in which 5'-DFUR, cisplatin and mitomycin C were administered. TP and DPD were measured by enzyme-linked immunosorbent assays after the objective responses to chemotherapy had been confirmed.

[Usefulness of 3D conformal radiation therapy for reduction of radiation-induced white matter injury].

Purpose: The usefulness of three-dimensional conformal radiation therapy(3DCRT) in decreasing radiation-induced white matter changes(WMC) was assessed.

Material And Methods: Thirty-seven patients(age 5-77 years, mean 42 years; male/female = 11/26) with primary intracranial tumors received 40 Gy or more, and were followed up with MRI for more than one year. Thirty-four patients underwent chemotherapy(with a platinum drug, 16; without a platinum drug, 18).