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Biomedical subjects

R Komaki

Publications and source records attributed to R Komaki.

At least 91 records · Page 5Linked to original sources
PubMed1995

Evaluation of cognitive function in patients with limited small cell lung cancer prior to and shortly following prophylactic cranial irradiation.

PURPOSE: Cognitive deficits after treatment for small cell lung cancer (SCLC) have been attributed to prophylactic cranial irradiation (PCI). A prospective study of neuropsychological function was undertaken to document the evolution and magnitude of neuropsychologic deficits. METHODS AND MATERIALS: Thirty patients with limited stage SCLC who responded well (29 complete response (CR), 1 partial response (PR)) to combination chemotherapy plus thoracic irradiation or resection were studied with neuropsychological tests in the cognitive domains of intelligence, frontal lobe function, language, memory, visual-perception, and motor dexterity prior to a planned course of PCI. Nine patients had a neurologic history that could influence testing. RESULTS: An unexpected 97% (29 out 30) of patients had evidence of cognitive dysfunction prior to PCI. The most frequent impairment was verbal memory, followed by frontal lobe dysfunction, and fine motor incoordination. Of the patients with no prior neurologic or substance abuse history, 20 out of 21 (95%) had impairments on neuropsychological assessment. This neurologically normal group was just as impaired as the group with such a history with respect to delayed verbal memory and frontal lobe executive function. Eleven patients had neuropsychological testing 6 to 20 months after PCI; no significant differences were found from their pretreatment tests. CONCLUSIONS: A high proportion of neurologically normal patients was limited SCLC and favorable responses to combination chemotherapy have specific cognitive deficits before receiving PCI. Short-term (6 to 20 months) observations after PCI have shown no significant deterioration.

Adult↗
PubMed1995

Carcinoma of the cervix: patterns of care studies: review of 1978, 1983, and 1988-1989 surveys.

PURPOSE: A review of the Patterns of Care Studies Process Survey data on carcinoma of the cervix conducted on patients in 1978, 1983, and 1988-89 was carried out to identify changes or trends in the demographics, evaluation, and treatment that might have occurred over this time period. METHODS AND MATERIALS: Patterns of Care Studies conducted surveys on patients treated by radiation therapy for cervical carcinoma in 1978, 1983, and 1988-89. These surveys have compiled demographic and treatment data on a total of 993 patients. There is outcome data for the 1978 and 1983 surveys, but not for the 1988-89 survey because follow-up has not been collected yet. The demographic and treatment delivery data on all three surveys has been reviewed and analyzed and is the subject of this study. RESULTS: There was no difference in the age distribution at the time of diagnosis of the patients in these surveys. The percentage of black patients remained constant in the three surveys, 19%, 17%, and 21%, respectively. The percentage of white patients was 76%, 78%, and 67%, but that of nonwhite/nonblack patients was 3%, 4%, and 12% (p < 0.001). The distribution of patients by stage was similar in the first two surveys. In the third survey, there was a decrease in the percentage of patients with Stage IA and IB (first = 35%; second = 38%; third = 29%) with a concurrent increase in Stage IIIA and IIIB patients (first = 20%; second = 18%; third = 26%). The surveys showed a major change in the pretreatment evaluation tests used. There was a progressive decrease in the use of intravenous pyelogram (IVP) (86 to 42%), barium enema (58 to 32%), cystoscopy for patients Stage IIB and higher (64 to 52%), and lymphangiography (18 to 14%). The use of abdominal or pelvic computed tomography dramatically increased from 6 to 70% between the first and third surveys. The use of 60Co units decreased from 35 to 2% from the first to the third survey [6 to 0% for short source-surface distance (SSD) 60Co units]. Point dose calculations for the intracavitary therapy increased from 78% in the 1978 survey to 95% in the third survey. As determined by the total dose delivered to the paracentral points, more patients (75.1%) were treated according to the Patterns of Care recommended guidelines in the 1988-89 survey than in the 1983 survey (63.6%). Chemotherapy was given to 12% of the patients undergoing radiation therapy during the period of the third survey, but these data are not available for the first and second surveys. CONCLUSION: Review of the Carcinoma of the Cervix Patterns of Care studies discloses significant changes in the demographics, patient evaluation, and radiation therapy techniques during the period of the studies. The potential impact of these changes on treatment outcome cannot be determined at this time until longterm follow-up for the 1988-89 survey is available, but improvements in the processes of care should lead to improvements in outcome.

Adult↗
PubMed1995

Interdigitating versus concurrent chemotherapy and radiotherapy for limited small cell lung cancer.

PURPOSE: Sequencing and timing of chemotherapy and radiotherapy for limited small-cell lung cancer (LSCLC) was studied in two consecutive trials. METHODS AND MATERIALS: In the interdigitating (IDG) trial, three cycles of COPE (cyclophosphamide 750 mg/M2 i.v. Day 1, vincristine 2 mg i.v. Day 8, cisplatin [DDP] 20 mg/M2 Days 1-3, etoposide 100 mg/M2 i.v. Days 1-3), were followed by thoracic radiation therapy (1.5 Gy bid 5-6 h apart, repeated twice at 3-week intervals) to give 45 Gy in 9 weeks; COPE was given during the intervals and for two more cycles. Operable patients had thoracotomy followed by IDG. Prophylactic cranial irradiation (PCI), 2.0 Gy x 15 fractions with a total dose of 30 Gy in 3 weeks, was given to the complete responders (CR) after completion of chemotherapy. In the concurrent (CON) trial, patients received DDP 60 mg/M2 i.v. Day 1, and etoposide 120 mg/M2 i.v. Days 1-3 for four cycles, every 3 weeks, and concurrent thoracic radiation therapy to 45 Gy with either 1.8 Gy daily, for 5 weeks or 1.5 Gy bid for 3 weeks. Prophylactic cranial irradiation (PCI) was given to the complete responders, 2.5 Gy daily for 2 weeks (25 Gy) (approximately 3 months after the initiation of treatment). RESULTS: The IDG group had 28 evaluable patients with median follow-up of 17.5 months. The CON group had 33 evaluable patients with median follow-up of 21 months. Overall survival rates for IDG patients were 79% at 1 year, 39% at 2 years, 30% at 3 years, and 27% at 4 years compared to 93%, 70%, 51%, and 46%, respectively, for the patients treated with CON (p = 0.01). Loco-regional recurrence (44%) and distant metastasis (48%) was more frequent as the first site of failure in the IDG group compared to the CON group (30% and 30%, respectively). Brain metastases constituted 30% of first metastases with IDG compared to none with CON. Esophagitis was significantly greater with CON. Hematologic and pulmonary toxicity were similar with IDG and CON. One death due to infection was seen in each treatment group. CONCLUSION: Concurrent chemoradiotherapy appears to be more effective than IDG. Earlier administration of PCI with concurrent chemotherapy and thoracic irradiation may reduce the risk of brain metastasis.

Adult↗
PubMed1995

Long-term results of treatment of cervical carcinoma in the United States in 1973, 1978, and 1983: Patterns of Care Study (PCS).

PURPOSE: To extend the observations of patients with carcinoma of the cervix treated in 1973 for over 15 years, in 1978 for over 10 years, and in 1983 for over 5 years for survival and local control to compare treatment times and outcome. METHODS AND MATERIALS: A nationwide survey of the patterns of practice in radiation therapy for patients with squamous carcinoma of the cervix collected pretreatment and treatment data using external surveyors who reviewed patients' records. Outcome information was updated for the three separate databases by mail survey. Overall survival, no evidence of disease (NED) survival, and local control curves by stage were plotted using the estimates derived by the Kaplan-Meier method. RESULTS: Total number of patients surveyed was 1686: 937 patients in 1973, 565 patients in 1978, and 184 patients in 1983. These are the results from changes in treatment policy, particularly the increasing use of brachytherapy. Of Stage III patients, the percentage receiving brachytherapy was 60.5% in 1973, 76.5% in 1978, and 87.9% in 1983 (p < 0.001 by linear trend test). Also, there was an increased proportion in use of higher energy for external pelvic irradiation during the more recent time period, e.g., 28% in the 1973 study, 60% in the 1978 study, and 87% in the 1983 study compared to the usage of cobalt-60 equipment. Comparison of results including overall survival, local control, and NED survival for the three different time periods showed improvement in outcome for Stage III in 1983, but not Stages I and II. The 5-year survival for Stage III increased from 25% in the 1973 survey to 47% in the 1983 survey, a linear trend that is statistically significant (p = 0.02). CONCLUSION: The long-term results of radiotherapy for patients with carcinoma of the cervix show improved outcome for Stage III patients, which probably results from improved treatment, including higher energy for pelvic irradiation and increase in use of brachytherapy contributing better local control and fewer complications.

Adult↗
PubMed1995

Radiation Therapy Oncology Group (RTOG) 88-08 and Eastern Cooperative Oncology Group (ECOG) 4588: preliminary results of a phase III trial in regionally advanced, unresectable non-small-cell lung cancer.

BACKGROUND: Regionally advanced, surgically unresectable non-small-cell lung cancer represents a disease with an extremely poor prognosis. External-beam irradiation to the primary tumor and regional lymphatics is generally accepted as standard therapy. The use of more aggressive radiation regimens and the addition of cytotoxic chemotherapy to radiotherapy have yielded conflicting results. Recently, however, results from clinical trials using innovative irradiation delivery techniques or chemotherapy before irradiation have indicated that patients treated with protocols that incorporate these modifications may have higher survival rates than patients receiving standard radiation therapy. PURPOSE: On the basis of these results, the Radiation Therapy Oncology Group (RTOG)-Eastern Cooperative Oncology Group (ECOG) elected to conduct a phase III trial comparing the following regimens: 1) standard radiation therapy, 2) induction chemotherapy followed by standard radiation therapy, and 3) twice-daily radiation therapy. METHODS: Patients with surgically unresectable stage II, IIIA, or IIIB non-small-cell lung cancer were potential candidates. Staging was nonsurgical. Patients were required to have a Karnofsky performance status of 70 or more and weight loss less than 5% for 3 months prior to entry into the trial, to be older than 18 years of age, and to have no metastatic disease. Of the 490 patients registered in the trial, 452 were eligible. The disease in 95% of the patients was stage IIIA or IIIB. More than two thirds of the patients had a Karnofsky performance status of more than 80. Patients were randomly assigned to receive either 60 Gy of radiation therapy delivered at 2 Gy per fraction, 5 days a week, over a 6-week period (standard radiation therapy); induction chemotherapy consisting of cisplatin (100 mg/m2) on days 1 and 29 and 5 mg/m2 vinblastine per week for 5 consecutive weeks beginning on day 1 with cisplatin, followed by standard radiation therapy starting on day 50; or 69.6 Gy delivered at 1.2 Gy per fraction twice daily (hyperfractionated radiation therapy). RESULTS: Toxicity was acceptable, with four treatment-related deaths. Three patients subsequently died of chronic pulmonary complications. Compliance with protocol treatment was acceptable. One-year survival (%) and median survival (months) were as follows: standard radiation therapy--46%, 11.4 months; chemotherapy plus radiotherapy--60%, 13.8 months; and hyperfractionated radiation therapy--51%, 12.3 months. The chemotherapy plus radiotherapy arm was statistically superior to the other two treatment arms (logrank P = .03). CONCLUSIONS: In "good-risk" patients with surgically unresectable non-small-cell lung cancer, induction chemotherapy followed by irradiation was superior to hyperfractionated radiation therapy or standard radiation therapy alone, yielding a statistically significant short-term survival advantage.

Adult↗
PubMed1995

Cognitive deficits in patients with small cell lung cancer before and after chemotherapy.

We conducted a prospective study of cognitive function in patients with small cell lung cancer (SCLC). A previous study had shown SCLC patients to have deficits in memory, frontal lobe executive functioning, and motor skills before they received prophylactic cranial irradiation (PCI). This study was performed to determine whether these deficits were related to chemoradiation treatment. We evaluated two groups of patients: one newly diagnosed and untreated, the other post-chemoradiation and before PCI. Strict eligibility criteria were used to minimize any preexisting factors that might influence cognitive functioning. Results showed that patients with SCLC have cognitive deficits before receiving chemoradiation, specifically on tests of verbal memory, frontal lobe executive functions, and motor coordination. There was no difference between the treated and untreated patients on any test. Etiologic considerations currently under study include paraneoplastic phenomena.

Adolescent↗
PubMed1995

Limited-stage small-cell lung cancer: patient survival after combined chemotherapy and radiation therapy with and without treatment protocols.

PURPOSE: To compare survival of patients who undergo treatment in protocols versus survival of patients not in protocols. MATERIALS AND METHODS: Records of 81 adult patients with small-cell lung cancer who underwent chemotherapy and radiation therapy in 1987-1992 were reviewed retrospectively. Forty-one patients were in a protocol; 40 patients were not. Patient demographics and prognostic factors were not statistically significantly different. RESULTS: Median overall survival was 16.7 months in the nonprotocol group versus 29.0 months in the protocol group (P = .0023). Median disease-specific survival was 18.3 months in the nonprotocol group versus 27.1 months in the protocol group (P = .0176). Survival was not statistically significantly influenced by Karnofsky performance status, weight loss, or thoracic radiation dose. CONCLUSION: There was a highly statistically significant difference in survival outcome in the nonprotocol group versus the protocol group (P = .0023). Differences in chemotherapy-radiation therapy timing and other treatment-related factors may have contributed substantially to the improved survival in the protocol group.

Adult↗
PubMed1995

Detecting recurrent or residual lung cancer with FDG-PET.

UNLABELLED: We investigated the diagnostic accuracy of FDG-PET in the detection of recurrent lung cancer. METHODS: Thirty-nine lesions in 38 patients with clinically suspected recurrent or residual lung cancer were studied with PET. All PET images were visually interpreted in conjunction with thoracic CT or MRI. Semiquantitative analysis using standardized uptake values (SUVs) was also performed in 25 lesions. FDG-PET diagnoses were correlated with pathological diagnoses and clinical outcome. RESULTS: The sensitivity and specificity of FDG-PET for detecting recurrent tumors were 100% (26/26) and 61.5% (8/13), respectively. The difference in mean SUV between recurrent tumors and noncancerous lesions was statistically significant [11.2 +/- 5.7 (n = 16) vs. 3.5 +/- 1.8 (n = 9), p < 0.0001]. False-positive results showed relatively lower SUVs than true-positives and also demonstrated increased uptake in a curvilinear rather than nodular shape. CONCLUSION: FDG-PET is useful for detecting recurrent lung cancer after treatment. False-positive diagnoses might be reduced by analysis of uptake shape and serial changes in SUV, but further study is needed.

Adult↗
PubMed1994

Thymoma. A retrospective study of 87 cases.

BACKGROUND: The authors retrospectively analyzed 87 patients with malignant thymoma treated at M.D. Anderson Cancer Center between 1951 and 1990. The analysis examined the clinical stages, histologic types, and treatment modalities and attempted to determine if chemotherapy had an impact on survival. METHODS: The patients were divided into three groups by their year of treatment and treatment modality. Patients treated between 1951 and 1975 were in Group I; patients treated between 1976 and 1980 were in Group II; and patients treated between 1981 and 1990 were in Group III. Most of the patients (18 [72%] in Group I; 16 [62%] in Group II; and 18 [50%] in Group III) had surgical resection alone or with radiotherapy. Patients with advanced-stage disease in Group I received single-agent chemotherapy, whereas patients with advanced-stage disease in Group II received a different, combination chemotherapy regimen, and those in Group III were treated primarily with cisplatin- and doxorubicin-based combination chemotherapy, e.g., the cyclophosphamide doxorubicin, and cisplatin with or without prednisone. The 17 patients treated with cisplatin with or without prednisone were separately evaluated for survival according to their response. RESULTS: Twenty-eight patients (5 [20%] in Group I; 6 [23%] in Group II; and 17 [47%] in Group III) received chemotherapy alone or after surgery or radiotherapy. The cisplatin with or without prednisone regimen was used in 17 Group III patients for initial treatment or for relapse. The overall response rate among the patients receiving the cisplatin with or without prednisone regimen was 64%; 6 (35%) had a complete response, and 5 (29%) had a partial response. Thirty-one (36%) of the 87 total patients had 45 recurrent tumors; the lung (29%), pleura (22%), and mediastinum (18%) were the most common sites of recurrence, whereas bone was the most common distant metastatic site. The 5-year survival rate was 70% in patients with Stage I disease, 71% in patients with Stage II or III disease, and 46% in patients with Stage IV disease. The 10-year survival rate was 70% in patients with Stage I disease, 47% in patients with Stage II or III disease, and 21% in patients with Stage IV disease. Statistical analysis indicated a significant difference among the survival rates of patients with noninvasive Stage I, invasive Stage II plus III (P = 0.033), and Stage II plus III and IV tumors (P = 0.056), but not between patients with Stage II or III tumors. Patients with a major response to the cisplatin with or without prednisone regimen had a significant survival improvement compared to those with no response (P = 0.002, log-rank test). CONCLUSIONS: Because thymoma is a chemosensitive tumor and frequently recurs in patients with Stage II or greater disease, chemotherapy carries a potential survival benefit and should be incorporated into the multimodality approach to prolong disease-free survival.

Adolescent↗
PubMed1994

Twice-daily fractionation of external irradiation with brachytherapy in bulky carcinoma of the cervix. Phase I/II study of the Radiation Therapy Oncology Group 88-05.

BACKGROUND: Hyperfractionated radiation therapy (HFX), which may permit higher total doses of radiation therapy without increased toxic effects to normal tissues, has been used with pelvic tumors, but its combination with brachytherapy has not been well studied. METHODS: A prospective Phase I/II trial was designed to study HFX with brachytherapy in patients with bulky Stage IB and IIA, IIB, III, and IVA carcinomas of the cervix. HFX doses of 1.2 Gy were administered to the whole pelvis twice daily at 4-6 hour intervals, 5 days per week; the total dose to the whole pelvis was 24-48 Gy. External pelvic irradiation was followed by one or two intracavitary applications to deliver the total minimum dose of 85 Gy at point A and 65 Gy to the lateral pelvic nodes. RESULTS: Eighty-one patients were enrolled in this protocol; 14% had Stage IB, 43% stage II, 38% stage III, and 4% stage IVA carcinomas. Seventy-one patients were evaluable for HFX and brachytherapy; 38 patients received one intracavitary application, and 33 received two applications. Four patients had Grade 3 acute reactions. The cumulative rates of Grade 3-4 late toxicities were 1.9% at 1 year, and 6.3% at 2 and 3 years. Of 80 patients evaluated for response, 80% had complete disappearance of disease. Comparisons with historical rates of late toxicity with standard fractionation (STD) revealed similar results in spite of higher total doses with HFX. Comparisons between historical STD and HFX also revealed equivalent rates of pelvic tumor control, Grade 3-4 toxicity, and survival at 3 years. CONCLUSIONS: Results suggest that combined with brachytherapy, HFX at total parametrial doses 10% above those used with STD was tolerated and at least as effective as STD. Further study with higher doses and extended fields is indicated. Comparisons of long term (5-plus years) survival and late-effects rates with STD versus HFX are planned.

Adolescent↗
PubMed1994

A randomized trial comparing perioperative chemotherapy and surgery with surgery alone in resectable stage IIIA non-small-cell lung cancer.

BACKGROUND: Patients with resectable stage IIIA non-small-cell lung cancer have a low survival rate following standard surgical treatment. Nonrandomized trials in which induction chemotherapy or a combination of chemotherapy and radiation prior to surgery were used to treat patients with regionally advanced primary cancers have suggested that survival is improved when compared with treatment by surgery alone. PURPOSE: We performed a prospective, randomized study of patients with previously untreated, potentially resectable clinical stage IIIA non-small-cell lung cancer to compare the results of perioperative chemotherapy and surgery with those of surgery alone. METHODS: This trial was designed to test the null hypothesis that the proportion of patients surviving 3 years is 12% for either treatment group against the alternate hypothesis that the 3-year survival rate would be 12% in the surgery alone group and 32% in the perioperative chemotherapy group. The estimated required sample size was 65 patients in each group. The trial was terminated at an early time according to the method of O'Brien and Fleming following a single unplanned interim analysis. The decision to terminate the trial was based on ethical considerations, the magnitude of the treatment effect, and the high degree of statistical significance attained. In total, 60 patients were randomly assigned between 1987 and 1993 to receive either six cycles of perioperative chemotherapy (cyclophosphamide, etoposide, and cisplatin) and surgery (28 patients) or surgery alone (32 patients). For patients in the former group, tumor measurements were made before each course of chemotherapy and the clinical tumor response was evaluated after three cycles of chemotherapy; they then underwent surgical resection. Patients who had documented tumor regression after preoperative chemotherapy received three additional cycles of chemotherapy after surgery. RESULTS: After three cycles of preoperative chemotherapy, the rate of clinical major response was 35%. Patients treated with perioperative chemotherapy and surgery had an estimated median survival of 64 months compared with 11 months for patients who had surgery alone (P < .008 by log-rank test; P < .018 by Wilcoxon test). The estimated 2- and 3-year survival rates were 60% and 56% for the perioperative chemotherapy patients and 25% and 15% for those who had surgery alone, respectively. CONCLUSIONS: In this trial, the treatment strategy using perioperative chemotherapy and surgery was more effective than surgery alone. IMPLICATIONS: This clinical trial strengthens the validity of using perioperative chemotherapy in the management of patients with resectable stage IIIA non-small-cell lung cancer. Further investigation of the perioperative chemotherapy strategy in earlier stage lung cancer is warranted.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1994

Protection by WR-2721 against radiation plus cis-diamminedichloroplatinum II caused injury to colonic epithelium in mice.

PURPOSE: The study was designed to investigate the ability of S-2-(3-aminopropylamino) ethylphosphorothioic acid (WR-2721) to protect mouse colon mucosa against damage produced by the combined radiation plus cis-diamminedichloroplatinum II (cis-DDP) treatment. METHODS AND MATERIALS: The mucosal damage was quantified by using microcolony assay, which measures the survival of epithelial cells in colon crypts. Radiation doses ranged from 8-24 Gy gamma rays. Cis-diamminedichloroplatinum at a dose of 13 mg/kg and WR-2721 at a dose of 400 mg/kg body weight were given IP before or after irradiation. RESULTS: Addition of cis-DDP to radiation within 24 h before and 48 h after irradiation reduced the number of crypt cells more than did radiation alone. The highest reduction was seen when the drug was given 2 or 6 h before irradiation: the damage was increased by a factor of 1.5. Protective effects of WR-2721 were tested in the radiation plus cis-DDP combination in which cis-DDP was given 2 h before or 2 h after radiation. In the former sequencing, WR-2721 was given 30 min before radiation (90 min after cis-DDP); damage was reduced more than the amount of damage contributed by cis-DDP (PF = 1.6). When cis-DDP was given 2 h after irradiation, WR-2721 was administered 30 min either before irradiation or 30 min before cis-DDP. Here, the protective effect was achieved only when WR-2721 was given before radiation: the PF was 1.3 in that case and only 1.1 when WR-2721 was given before cis-DDP. Thus, WR-2721 must be given before irradiation, but even then the degree of protection achieved depends on whether cis-DDP is applied before or after irradiation, with the protection being greater in the former situation. CONCLUSION: Our observations showed that WR-2721 is a potent protector against the injury of mouse colon mucosa produced by the combined radiation plus cis-DDP treatment. They have important implications in the clinic, indicating that proper timing of WR-2721 administration is crucial for preventing side effects of the cis-DDP and radiotherapy combination, where damage to mucosal epithelial cells is dose limiting.

Amifostine↗
PubMed1994

Dose intensity of radiation therapy in non-small cell carcinoma of the lung: a review of RTOG data and strategies.

Prospective trials exploring questions of dose intensity for control of the local-regional tumor have been conducted by the Radiation Therapy Oncology Group for 20 years. Early studies established radiation therapy with a total dose of 60 Gy in 30 fractions as standard (STD) for unresectable non-small cell carcinomas of the lung (NSCCL). Hyperfractionated radiation therapy (HFX) with 1.2 Gy twice daily permitted higher total doses without increased normal tissue effects and led to comparison of STD vs. HFX (total dose 69.6 Gy in 58 fractions). Induction chemotherapy followed by STD, induction followed by concurrent chemotherapy and STD, and concurrent chemotherapy and HFX, have been explored in successive trials. Preliminary results of STD combined with chemotherapy suggest that increases in dose intensity increase local-regional control and survival. Confirmatory trials of increased dose intensity by combining chemotherapy with STD and HFX have been completed or are progressing.

Antineoplastic Combined Chemotherapy Protocols↗