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At least 649 records · Page 36Linked to original sources

PubMed1994

Taxol (paclitaxel) in the treatment of lung cancer: the Eastern Cooperative Oncology Group experience.

Two phase II studies of paclitaxel involving patients with advanced non-small cell lung cancer (NSCLC) have been completed. The first study, conducted by the Eastern Cooperative Oncology Group (ECOG), involved 25 previously untreated patients who received intravenous (i.v.) paclitaxel 250 mg/m2 over 24 hours every 3 weeks. Among 24 evaluable patients with stage IV disease, 5 partial responses (21%) were observed, median survival was 24.1 weeks, and 1-year survival was approximately 45%. Common toxicities included leukopenia (66% grade 4), neurotoxicity (28% grade 3), and cardiotoxicity (12.5% grade 3). The second trial, conducted at the M.D. Anderson Cancer Center, yielded similar results. Twenty-seven previously untreated patients with stage IV disease received paclitaxel 200 to 250 mg/m2 i.v. over 24 hours every 3 weeks, yielding 1 complete response and 5 partial responses (24%) in 25 evaluable patients. The major toxicity was leukopenia. No cardiac toxicity was seen. For the past several years ECOG has tested several agents against previously untreated NSCLC, and none has demonstrated a response rate greater than 10%, other than paclitaxel. Given these results, the ECOG plans to conduct a three-arm phase III study involving patients with advanced NSCLC comparing 'standard' cisplatin/etoposide chemotherapy to two paclitaxel-containing arms: (1) paclitaxel 135 mg/m2 i.v. over 24 hours plus cisplatin 75 mg/m2 i.v.; (2) paclitaxel 250 mg/m2 i.v. over 24 hours plus cisplatin 75 mg/m2 i.v. plus recombinant human granulocyte colony-stimulating factor.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1996

Diagnostic significance of electrocochleogram and auditory evoked brainstem response in totally or subtotally deaf patients.

This paper examined the use of ECoG and ABR in 7 patients with totally or subtotally deaf ears. The patients included one with cortical deafness, one with psychogenic deafness, one with intrapontine hemorrhage, and 4 with acoustic neuroma. In patients with substantial hearing loss, ECoG should be performed first if retrocochlear disorders are suspected since results may be obtained even in the absence of other auditory evoked potentials. Simultaneous ABR measurements can be effective when localizing retrocochlear lesions. ECoG can also help to determine the need for preserving hearing during surgery for retrocochlear lesions by indicating the degree of cochlear function.

Adult↗

PubMed1996

Abnormal electrocochleography after excision of acoustic neuroma.

Pre-, per- and post-operative ECoG findings obtained from a 43-year-old woman with an acoustic neuroma were studied. Although CAP presented a normal waveform in response to click during the whole process of the operation, it was transformed into an abnormally broadened negative waveform in shape with a mild hearing exacerbation, and has remained unchanged up to the present. This broad response was considered to be a receptor potential, because it showed no adaptational amplitude reduction. Additionally, postoperative ECoG to tone burst stimuli demonstrated an increase in DC potential following the stimulus envelope. Consequently, the broad negative response to click was considered to be mainly composed of an enlarged negative SP. The generation mechanism underlying the phenomenon of an abnormally increased negative SP found after the excision of an acoustic neuroma is discussed, with reference to several items in the literature. Similar responses in the postoperative ECoG of patients with acoustic neuromas obtained by us in the past were given as additional examples. CAP as an indicator for intraoperative monitoring can hardly predict postoperative auditory function. It is to be hoped that a more reliable auditory monitoring method during the operation will be established.

Adult↗

PubMed1996

Paclitaxel doublets in metastatic breast cancer: Eastern Cooperative Oncology Group and Hoosier Oncology Group Studies.

The recognition of the activity of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) in metastatic breast cancer led to attempts to combine this drug with other active agents. Two agents that have received particular attention are doxorubicin and cisplatin. Initial pilot and phase I trials by the Eastern Cooperative Oncology Group (ECOG) led to the development of a three-arm, prospective randomized trial comparing single-agent doxorubicin, single-agent paclitaxel, and the combination of doxorubicin and paclitaxel (E 1193). This trial is currently closed to accrual and the initial results are being analyzed. Based on data from Gianni et al (J Clin Oncol 13:2688-2699, 1995), the ECOG is currently involved in two trials attempting both to confirm the superior activity of the regimen used by Gianni et al and, in a phase I/II trial, to ameliorate its cardiac toxicity through the addition of dexrazoxane. Similarly, both the ECOG and the Hoosier Oncology Group were unable to confirm the strikingly positive results obtained by the Vancouver group when cisplatin was combined with paclitaxel (Semin Oncol 22:108-111, 1995 [suppl 6]: Proc Am Soc Clin Oncol 13:71, 1994 [abstr 88]). Indiana University investigators are currently involved in a phase I trial attempting to combine carboplatin and paclitaxel in a biweekly schedule.

Antibiotics, Antineoplastic↗

PubMedDate not supplied

Electrocorticogram changes caused by subchronic lead treatment of rats.

Male Wistar rats were treated per os through gavage for 4, 8 and 12 weeks by 80.0, 160.0 and 320.0 mg/kg lead in form of lead acetate. The changes of certain parameters (mean frequency, mean amplitude, ECoG index-the ratio of the slow and fast bands, power spectrum of the frequency bands) of the electrocorticogram (ECoG) recorded from the primary somatosensory, visual and auditory centres of anaesthetized rats were analysed. The data show that all investigated parameters had dose- and time-dependent changes: increased mean frequencies accompanied by decreased mean amplitudes and ECoG-indices. These changes were significant only at the highest, or at the two higher dose groups by the end of the experiment. The data suggest that subchronic, low-level exposure of lead can affect the integrated electrophysiological function of the brain.

Animals↗

PubMedDate not supplied

Prognostic implications of c-Ki-ras2 mutations in patients with advanced colorectal cancer treated with 5-fluorouracil and interferon: a study of the eastern cooperative oncology group (EST 2292)

PURPOSE: Mutations in c-Ki-ras2 (ras) occur in about 40% of patients with colorectal cancers and occur early in the pathogenesis of this disease. To evaluate the prognostic value of mutations in ras, the Eastern Cooperative Oncology Group (ECOG) conducted a retrospective study (EST 2292) to determine the frequency of mutations in patients with advanced colorectal cancer, and to determine whether ras mutations were associated with altered response to therapy and survival. PATIENTS AND METHODS: Patients were enrolled from four studies: P-Z289, an ECOG phase II trial of 5-fluorouracil (5-FU) and interferon (IFN) in patients with advanced colorectal cancer; P-Z991, an ECOG phase I trial of 5-FU and IFN in patients with advanced malignancies; and two trials from the Albert Einstein College of Medicine in patients with advanced colorectal cancer treated with 5-FU and either IFN-alpha or IFN-beta. All patients had advanced colorectal carcinoma and had sufficient histologic material available for analysis for the presence and type of ras, using polymerase chain reaction and dot-blot analysis with sets of probes sufficient to detect all the common mutations of ras at codons 12, 13, and 61. RESULTS: Seventy-two patients were enrolled in this trial. Mutations in ras were detected in 25 (35%), including 17 (23%) in codon 12, four (6%) in codon 13, and four (6%) in codon 61. There was no correlation between the presence of a ras mutation and age, sex, Dukes' stage, histology, or tumor markers. Thirty-one of 72 patients (43%) responded to therapy with 5-FU and IFN, and 10 of 31 responders (32%) and 15 of 41 nonresponders (37%) had mutations in ras. There was no difference in response rates or overall survival between the groups with and without ras mutations. CONCLUSIONS: It is unlikely that ras mutations will have significant prognostic value for either response to therapy or survival in patients with colorectal carcinomas treated with 5-FU and IFN.

Adult↗

PubMed1998

[The comparison of ketamine with methohexital and thiopental in the intraoperative EEG in drug-resistant epilepsy].

UNLABELLED: The acute (ECoG) was examined in 291 patients with intractable epilepsy, without structural brain lesion--from 1971 to 1997. Temporal lobectomy was performed in 198 cases and extratemporal (frontal, parietal or occipital) in remaining 93 cases to achieve seizure control. Epileptic foci was activated during acute ECoG by i.v. administration of ketamine (154 cases) or short-acting barbiturates--methohexital (110 cases) and thiopental (27 cases). RESULTS: Ketamine significantly more often caused ECoG identified electrographic seizures than methohexital: p = 0, 00001 or thiopental, which in no cases resulted in seizures. Also electrographic seizures occurred more frequently after administration of ketamine in patients with the extratemporal seizure focus localisation in comparison with temporal focus (p < 0.05). Electrographic seizures provoked after administration of ketamine improved the localisation of the area to be resected, more often in extratemporal epileptic foci. CONCLUSIONS: The results of our investigations indicate that ketamine more effectively activated epileptic focus than short-acting barbiturates.

Adolescent↗

PubMed1998

Quality of life in patients with cancer of the esophagus and gastric cardia: a case for palliative resection.

OBJECTIVE: To evaluate quality-of-life (QOL) parameters in patients undergoing esophagectomy, curative or palliative, for carcinoma. DESIGN: Nonconsecutive case series. PATIENTS: Eighty-eight patients who underwent esophagectomy for cancer (curative, n=49 [56%]; palliative, n=39 [44%]) provided QOL assessments over an 18-month period. SETTING: Procedures for referral care were performed by a single team of clinicians in a tertiary referral center. Evaluations of QOL were made by 1 independent trained investigator. OUTCOME MEASURES: Data were documented by questionnaire at interview and parameters evaluated included an esophageal module for the type and quantity of food intake, severity of related symptoms on eating, Eastern Cooperative Oncology Groups (ECOG) performance status, sleep, pain, leisure activity, working capacity, outlook on life, general well-being, and support from family and friends. A summation of selected parameters was used to calculate a total score. RESULTS: Significant improvements were recorded in both the curative and palliative groups for at least 1 year following surgery in the type (P<.03) and quantity (P<.03) of food intake and severity of diet-related symptoms (P<.02), when compared with preoperative considerations. Findings were comparable between the groups with regard to dietary intake. Pain status and total scores were worse in the palliative group at 9 months postoperatively but no significant differences between the groups were evident at any time for sleep, leisure activity, and ECOG performance status. CONCLUSIONS: To our knowledge, there are no previous data regarding a comparison of QOL considerations in patients who have undergone either potentially curative or palliative esophagectomy for malignant disease. Data analysis revealed that palliative esophagectomy provided enhanced QOL with marked symptomatic benefits and enjoyment of daily living comparable to that observed following curative resection.

Cardia↗

PubMed2000

Deoxycoformycin in the treatment of patients with hairy cell leukemia: results of a Spanish collaborative study of 80 patients.

BACKGROUND: Deoxycoformycin (DCF) has been reported to produce high response rates in patients with hairy cell leukemia (HCL), but to the authors' knowledge data regarding experience with such therapy in a large HCL series are scarce. METHODS: Between 1988-1997, DCF (4 mg/m(2)/day, every 2 weeks) was administered to 80 HCL patients in 32 Spanish institutions. In 35 of 78 evaluable patients DCF was the first-line therapy; the remaining 43 patients had received other therapies. Pretreatment variables influencing the achievement of complete remission (CR) and event free survival were identified by multivariate analyses. RESULTS: The median number of cycles administered was 7 (range, 1-22 cycles). A CR was obtained in 56 patients (72%) and a partial remission was obtained in 13 patients, for an overall response rate of 88%. In the multivariate analysis previous splenectomy and an Eastern Cooperative Oncology Group (ECOG) performance status > or = 2 were the parameters adversely influencing CR achievement. With a median follow-up of 31.2 months (range, 0.4-126.5 months), disease recurrence was observed in 11 of the CR patients, 5 of whom showed a further response to DCF. An ECOG performance status > or = 2 was the only pretreatment variable associated with a shorter event free survival. Seven patients died, four during the treatment period. The actuarial median event free survival was 46 months (95% confidence interval, 22.5-69.5 months), and 48.7% of the 56 patients who achieved a CR were expected to be alive and disease free at 5 years. Hematologic toxicity (marked neutropenia [22 cases], anemia [6 cases], and thrombocytopenia [1 case]) was the main side effect, followed by nausea and emesis (5 cases); 14 patients required hospitalization. CONCLUSIONS: The results of the current study confirm the effectiveness and acceptable toxicity of DCF in the treatment of patients with HCL.

Aged↗

PubMed1998

Objective method for localization of cortical asymmetries using positron emission tomography to aid surgical resection of epileptic foci.

We designed a semiautomated method for the objective detection of abnormal regions of tracer accumulation in the brain. The purpose of the present study was to examine the diagnostic performance of this method by applying it to patients with clinically intractable epilepsy of unilateral origin; they underwent [F-18] deoxyglucose positron emission tomography (PET) prior to surgical resection of epileptic foci. A semiautomated method for assessment of asymmetries in the brain cortex was developed that compares activity concentrations in homotopic cortical areas. When these differences exceeded a predefined threshold, the areas with lower activity were marked and 3-dimensional surface rendered images were created to guide placement of intracranial electrodes (ECoG) followed by surgical resection. The normal amount of asymmetry between small (0.5-0.7 cm2) homotopic cortical regions was determined as 5.9 +/- 4.0% (mean +/- SD). The false-positive fraction was determined for cutoff thresholds of 1 SD (10%), 1.5 SD (12%), and 2 SD (15%) outside the mean and was found to be 89, 44, and 0%, respectively. The obtained sensitivity-specificity pairs for correct localization of epileptogenic lobes based on the ECoG results were best for the 15% threshold (80/94%, accuracy 0.90). This objective PET method allows the accurate determination of cortical asymmetries, and it proved to be highly efficient in guiding epilepsy surgery.

Adolescent↗

PubMedDate not supplied

Cardiorespiratory effects of O-isobutyl S-[2-(diethylamino)-ethyl] methylphosphonothioate -- a structural isomer of VX.

O-Isobutyl S-[2-(diethylamino)ethyl]methylphosphonothioate (VR) is a structural isomer of a more well-known chemical warefare agent, O-ethyl S-[2(diisopropylamino)ethyl]methylphosphonothioate (code designation VX). In this study, cardiorespiratory and central nervous system (CNS) effects of VR (2LD50 or 22.6 microg kg(-1); s.c.) were evaluated in urethane-anesthetized (Group 1) and unanesthetized (Group 2) guinea pigs instrumented for concurrent recordings of electrocorticogram (ECoG) and a variety of cardiorespiratory activities. The first sign of intoxication was a state of progressive bradycardia, vascular hypotension and arrhythmia (Group 1, approximately 13 min post-VR; Group 2, approximately 6 min post-VR). Bradypnea, excessive salivation and compensatory changes in blood pressure typically did not emerge until 3-5 min prior to apnea (Group 1, approximately 28 min post-VR; Group 2, approximately 15 min post-VR). An idioventricular rhythm, which signalled a failing myocardium, appeared at the same time or shortly after the development of a bradypneic profile. Another notable toxicity component of VR, based on arterial pH, pO2/pCO2 and bicarbonate (HCO3-) level data, was a state of combined hypercapnia, acidemia and hypoxemia during the development of bradypnea. Taken together, findings from this study indicated that changes in medullary respiratory unit activity and ECoG data displayed little, if any, notable signs of CNS perturbation prior to the terminal stage (approximately 1 min prior to respiratory failure). Thus, in addition to displaying a greater sensitivity to perturbation by VR, the peripheral cardiorespiratory system components also appeared to play a more important role in precipitating a progressively dysfunctional cardiorespiratory status that ultimately led to collapse of central respiratory mechanisms and death.

Acidosis↗

PubMed1984

Primary liver cancer. An Eastern Cooperative Oncology Group Trial.

One hundred ninety-two patients with unresectable primary liver cancer studied by members of the Eastern Cooperative Oncology Group (ECOG) were evaluable in a prospectively randomized clinical trial. Patient discriminants such as performance status were carefully evaluated to assess their influence on prognosis and to evaluate the importance of patient status on response and survival. Patients who were totally bedridden or with signs of overt liver failure were not entered on study. The median survival time for all evaluable previously untreated patients was 17 weeks (19 weeks for North American and European, and 10 weeks for South African black patients). Among the South African patients, however, there was a significantly larger proportion with an initially poor performance status. Prognostic variables (performance status, jaundice, and reduced appetite) dominate any differences among the treatments studied. Among North American and European patients on intravenous (IV) 5-fluorouracil (5-FU) + Methyl-CCNU (MeCCNU) + Adriamycin (ADM, doxorubicin), the 19% response rate is offset by 63% with severe toxicity and a median survival time of only 17 weeks, making this treatment unacceptable clinically. The median survival time of North American and European patients treated with IV 5-FU +/- MeCCNU was 28 weeks in contrast to a median survival time of 12 weeks with ADM (P less than or equal to 0.01). EST 2273 was the ECOG study of patients with primary liver cancer. The results of the first part of the trial were published in 1978. This report updates those findings and reports the results of patients entered subsequently on the second part of that study after it was amended in 1979. With more than 300 evaluable patients in EST 2273, this duet of studies is the largest ever conducted in patients with primary liver cancer, and draws a new baseline from which to measure the disease and its response to treatment.

Adenoma, Bile Duct↗

PubMed1984

Phase II study of recombinant leukocyte A interferon (rIFN-alpha A) in disseminated malignant melanoma.

Thirty-one patients with disseminated malignant melanoma received intramuscular recombinant leukocyte A interferon (rIFN-alpha A), 50 X 10(6) units/m2 three times weekly for a planned treatment duration of 3 months. Seven objective regressions (23%), which ranged in duration from 3 to 11.2+ months, were observed. Forty-two percent of 12 patients who were fully active (Eastern Cooperative Oncology Group [ECOG] performance score, 0) responded compared to 11% of 19 patients with impairment of performance status (ECOG, 1-3). Prior chemotherapy did not influence response rate. For all patients the median time to progression and of survival was 2 months and 6 months, respectively. Four patients had partial regressions in soft tissue (3, 4.6 months), pulmonary (7 months), and prostatic lesions (3 months). The latter was biopsy-proven and assessed by serial computerized tomography (CT) scans. Three had complete regressions of soft tissue disease (2 patients, 6.4 and 10+ months each), and liver involvement (11.2+ months). The major toxicities were moderate to severe fatigue (87%), anorexia (58%), and confusion (23%). Performance score deteriorated in 84% of patients during the time they were receiving rIFN-alpha A. Among the 13 patients whose tumors did not progress for at least 12 weeks, 7 required dose reductions or termination of treatment due to toxicities. Hematologic and hepatic toxicity was transient and of little clinical significance. The study indicates that rIFN-alpha A has some antitumor activity accompanied by difficult side effects in patients with disseminated malignant melanoma.

Adult↗

PubMed1985

Pancreatic cancer. Assessment of prognosis by clinical presentation.

Three hundred ninety-three patients who were entered into pancreatic carcinoma treatment protocols of the Gastrointestinal Tumor Study Group (GITSG) were analyzed as to significant differences in clinical presentation and factors influencing survival. Patients were grouped according to the stage of the disease. Group I (21 cases) included those patients who had a potentially curative resection. Group II (182 cases) patients had a locally unresectable tumor less then 400 cm2 (surgically proven) and no distant metastases, and Group III (190 cases) had advanced disease. Group I patients had the smallest lesions (median area, 9 cm2), located in head of the gland in 90% and painless jaundice was the most frequent clinical presentation (52%). In Group II, 83% were located in the head of the gland but the median area was much larger (36 cm2). Pain was present in 80% of cases, and jaundice in 62% with 48% having jaundice and pain. In Group III patients, lesions of body and tail were over four-fold as frequent as in Group I and almost three-fold greater than in Group II. The median area of the lesion was large (30 cm2). Pain was present in 85% and jaundice in only 31%. Median survival in Group I patients was longer than Group III (73 versus 10 weeks; P less than 0.001). Ambulatory status, sex, race, abdominal pain, and histologic type influenced survival in one or more groups whereas age, jaundice, location of the tumor, degree of cellular differentiation, back pain, and nutritional status did not influence survival in any group. In all groups, those with a good performance status (Eastern Cooperative Oncology Group [ECOG] 0 and 1) survived longer than those with poor status (ECOG 2 and 3; P less than 0.05). The best potential prognosis is in those who are fully productive and present with painless jaundice, and who have resection of the tumor.

Adenocarcinoma↗

PubMed1994

Current trials and future directions of the Eastern Cooperative Oncology Group Breast Cancer Committee.

The Eastern Cooperative Oncology Group (ECOG) continues a major commitment to clinical trials in breast cancer. Trials nearing completion address adjuvant therapy in patients with negative nodes and the interaction of hormonal and cytotoxic adjuvant therapies. ECOG is committed to the performance of intergroup trials that are coordinated among the other major cooperative clinical trials groups in order to accrue the large numbers of patients required for optimal definition of trial results in as few years as possible. Most adjuvant trials to begin the months and years ahead will involve such collaboration. Issues to be addressed include the adjuvant benefit of ovarian ablation (surgical or medical) in addition to tamoxifen in the adjuvant therapy of women at relatively low risk; the significance of increasing dose intensity by a variety of techniques for the adjuvant therapy of women at higher risk of recurrence, including the use of autologous bone marrow transplantation and stem cell support with dose-intense therapy for women at the highest risk of recurrence; and the issue of combination scheduling of cytotoxic agents versus sequential single agents at higher dose intensity.

Breast Neoplasms↗

PubMed2000

Vinorelbine in elderly patients with inoperable nonsmall cell lung carcinoma: a phase II study.

BACKGROUND: Cancer in the elderly is becoming a complex and frequent issue. At least 30% of lung carcinomas are expected to arise each year in elderly patients, who often have significant comorbidity. The most appropriate treatment for this large portion of cancer patients remains unknown. The purpose of this Phase II trial was to make a comprehensive evaluation of the activity, toxicity, and tolerability of single-agent vinorelbine in elderly and relatively poorly performing patients with inoperable nonsmall cell lung carcinoma (NSCLC). METHODS: Patients age 70 years or older were eligible to participate in this trial if they had a pathologic diagnosis, a performance status lower than 4 (Eastern Cooperative Oncology Group [ECOG] scale), and gave informed consent. Vinorelbine was given intravenously (i.v.) at a dose of 25 mg/m(2) every week until progression, persistent toxicity, or refusal. RESULTS: Forty-six patients entered the study; their median age was 75 years (range, 70-83 years). Five patients never started on vinorelbine; 27 others had early treatment suspensions. The median number of weekly infusions was 5 (range, 0-28); the median dose intensity was 70% of projected. Toxicity was generally mild, mainly hematologic, and never life-threatening. ECOG performance status, body weight, and almost all the scores from the quality-of-life questionnaires remained constant during the first 6 weeks of treatment. Two patients obtained partial response, 10 patients had some tumor regression, and 26 had tumor stabilization. The estimated median time to progression was 19 weeks (quartile range, 11-23 weeks), and the median survival 34 weeks (quartile range, 16-63 weeks). CONCLUSIONS: In our group of patients who had poor prognoses, vinorelbine was well tolerated, moderately active, and capable of ensuring relatively long survival. It may represent a valuable therapeutic option for the treatment of nonresectable NSCLC in elderly patients.

Age Factors↗

PubMed1991

High-dose dexamethasone for refractory or relapsing multiple myeloma.

In order to assess the efficacy and toxicity of dexamethasone as a single agent without the concomitant infusion of Adriamycin and vincristine (VAD), an ECOG pilot study was initiated using 40 mg by mouth daily for 4 days every week for 8 weeks. Patients who responded were then maintained on the same treatment, but at 2 week intervals. Of the 32 patients evaluable for response, three were completely refractory to all prior therapy. All patients had advanced disease and 26 had received multiple prior treatments. There were 13/32 (40%) objective responses by ECOG criteria. Of the 28 patients evaluable for subjective response, i.e., significant decrease in performance status and/or bone pain, eight (28.5%) responded. Of the 34 patients evaluable for toxicity, 19 patients (55%) had moderate to severe side effects, including nine who had central nervous system effects, three who had gastrointestinal bleeding, two who had pulmonary emboli, one with psychosis, and four who had serious infections with one death. Median survival for the entire group was 19 weeks, with 31 weeks in the responders and 9 weeks in the non-responders. Although high-dose dexamethasone is capable of producing a significant number of partial responses (40%), it is associated with excessive toxicity. Less frequent administration of the dexamethasone at 2 week intervals was well tolerated in the maintenance of partial response, but has not been studied for efficacy in induction of remission.

Adolescent↗

PubMed2002

Financial analysis of patients with newly diagnosed acute myelogenous leukemia on protocol or standard therapy.

BACKGROUND: Medicare and third-party payers may be reluctant to pay for investigational (protocol) therapy for patients with cancer on the premise that such treatment is more expensive than standard therapy. However, prior studies that have attempted to compare protocol therapy with standard therapy have been difficult to interpret because of the assortment of malignancies studied and the lack of suitable control groups of patients who received standard therapy. METHODS: In the current study, the authors conducted a retrospective review of the financial charges associated with protocol or nonprotocol (standard) chemotherapy in patients with a single malignancy, newly diagnosed acute myelogenous leukemia (AML), who received their initial course of chemotherapy ("induction") at the Memorial Sloan-Kettering Cancer Center (MSKCC) between 1996 and 1999. Protocol and nonprotocol groups were analyzed according to clinical characteristics and standard prognostic features to determine whether the two groups were comparable. Median charges for all patients were determined using a database that linked clinical information, financial data, and clinical outcomes. RESULTS: A total of 353 patients with newly diagnosed AML were registered at MSKCC during the time period studied; of these, 79 patients (22%) received all of their care at the institution. Thirty patients (38%) received treatment on an investigational protocol. Forty-nine patients (62%) did not receive protocol therapy for the following reasons: 10 patients (20%) did not meet eligibility criteria, 4 patients (8%) were eligible for protocol therapy but declined, and 35 patients (71%) met protocol criteria but were not offered protocol therapy based on the judgment of their primary oncologist. The groups were not comparable because patients treated with standard therapy were older and had a poorer initial Eastern Cooperative Oncology Group (ECOG) performance status. Overall median charges for patients in the nonprotocol group were higher than for patients treated on a protocol although charges were not related to age, initial ECOG performance status, or cytogenetic risk group. CONCLUSIONS: Although charges for the nonprotocol group were higher, specific factors responsible for this difference were not identified. This study emphasizes the problems inherent in assembling suitable groups of patients for comparison.

Adult↗