Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “Karnofsky Performance Status”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 361 records · Page 20Linked to original sources
PubMed1995

Speech and language disorders in patients with high grade glioma and its influence on prognosis.

One hundred and sixteen patients with high grade glioma were entered into a prospective phase two study and treated with accelerated radiotherapy from 1988 to 1993. In this cohort of patients we analysed speech deficit as a subdivision of global functional status in terms of incidence, category and prognosis for survival. Forty three patients (37%) had a speech deficit at presentation. Eighty percent of these had a component of expressive dysphasia, associated with considerable degree of awareness and distress. The overall median survival was 9.5 months. On univariate analysis, median survival in patients with speech difficulties (6 months) was worse than patients with normal speech (10.5 months) (log rang p = 0.005). Multivariate analysis established independent significance from age, Karnofsky Performance Status (KPS), gender, histological grade, extent of surgery and seizures. This paper highlights the importance of assessing individual categories of functional disability which in patients with high grade glioma include mobility, cognitive function and communication. Each of these factors may seriously affect an individual's activities of daily living, hence quality of life and separate analysis has a number of clinical implications. Firstly, with over a third of patients suffering speech difficulties, adequate speech therapy facilities should be freely available to score the degree of deficit, devise coping strategies and institute communication therapy. Secondly, an understanding of prognostic factors aids the critical analysis of phase two studies and the design and stratification of future prospective trials which should include an analysis of speech deficit. Thirdly, separating individual patients into good and bad prognostic groups can assist strategic management decisions.

Adult↗
PubMed1993

Extended follow-up in 212 long-term allogeneic bone marrow transplant survivors. Issues of quality of life.

A group of 235 allogeneic marrow recipients were contacted at least one year following their BMT to obtain information on their quality of life; 212 (90%) agreed to participate in this survey. A total of 162 adults and 50 pediatric survivors were interviewed during clinic visits (5%) or over the telephone (95%). Changes in productive activity and marital status at the time of interview were studied, as well as the presence of physical symptoms and perception of a general sense of well-being. Older transplant recipients were observed to have a significantly higher incidence of chronic graft-versus-host disease, common colds, and skin changes when compared with pediatric transplant recipients (P < 0.01). Older subjects were also more likely to require any type of regular medication. Younger survivors were rated with a higher Karnofsky performance status and global subjective score. There were no significant differences between patients who received TBI as part of the conditioning regimen and those who did not, with the exception of increased cataract development in pediatric patients receiving TBI (P < 0.008). We conclude that most allogeneic marrow transplant survivors, especially those individuals of younger age at the time of their transplants, are doing well in the domains tested.

Adolescent↗
PubMed1993

Depressive symptoms, medical illness, and functional status in depressed psychiatric inpatients.

OBJECTIVE: There is evidence that both psychiatric (especially affective) and medical illnesses contribute to physical disability. However, the differential contributions of specific psychiatric disorders and of medical pathology to functional status in psychiatric populations have not been studied. The authors therefore examined the contributions of depressive symptoms and medical illness to functional disability in depressed inpatients. METHOD: This prospective investigation included 109 psychiatric inpatients with DSM-III-R major depression. Regression techniques were used to examine the contribution of demographic variables (age, sex, education), depressive symptom severity (Hamilton Rating Scale for Depression score), psychiatric function (Global Assessment of Functioning Scale score), organ system pathology (Cumulative Illness Rating Scale score), and medical disability (Karnofsky Performance Status Scale score) to overall functional status (Instrumental Activities of Daily Living and Physical Self-Maintenance scores). These relationships were also examined in older and younger subgroups. RESULTS: Greater age, female sex, and illness factors all contributed to poorer functional status. Of the illness factors, psychiatric pathology contributed more to low functional status than did medical illness. The predictive power came specifically from the functionally based measures of psychiatric and medical illness; a quantitative measure of symptoms (Hamilton depression scale) or organ pathology (Cumulative Illness Rating Scale) did not significantly predict overall functional status. CONCLUSIONS: Clinicians and researchers should recognize that symptomatic and functional assessments tap related but different domains and that both psychiatric and medical illnesses contribute to overall disability.

Activities of Daily Living↗
PubMed2004

Social support, anxiety and depression after chemotherapy for ovarian cancer: a prospective study.

OBJECTIVES: We aimed to describe the levels of anxiety and depression in patients during the 3 month period following the end of chemotherapy treatment and to identify factors that predict psychological morbidity. METHOD: We performed a prospective study in women with ovarian cancer to determine the changes in psychological status in the 3 months following completion of chemotherapy. Sixty-three consecutive patients were assessed at the completion of chemotherapy (Time 1) and 57 at 3 months follow-up (Time 2). Relevant disease and patient characteristics were recorded and patients were assessed at Time 1 for anxiety, depression and their perception of emotional support, an index of their psychosocial environment. Anxiety and depression were re-assessed at Time 2. RESULTS: The results indicate significant initial psychological morbidity, with clinical caseness for anxiety (38%) and depression (33%) being common. Follow-up at Time 2 shows that patients undergo a significant reduction in cases (19%) and symptoms of depression but an increase in cases of anxiety (47%). The principal factors associated with symptoms of anxiety at Time 2 were poor perceived social support, increased intrusive thoughts and, to a lesser extent, younger age. Medical parameters, such as the stage of disease, response of the cancer to treatment, Ca125 (a tumour glycoprotein) and Karnofsky Performance status (a measure of how well the patients is) were not associated with worse psychological outcome. CONCLUSION: These data show for the first time that social support and intrusive thoughts, rather than physical parameters, are the principal determinants of psychological morbidity in patients with ovarian cancer.

Adult↗
PubMed2002

Palliation of advanced/recurrent esophageal carcinoma with high-dose-rate brachytherapy.

PURPOSE: The aim was to assess the improvement in swallowing status, complication rate, and overall survival. PATIENTS AND METHODS: Fifty-eight patients with advanced/recurrent esophageal carcinoma were treated for palliation with high-dose-rate intraluminal brachytherapy (HDR-ILRT) with a remote afterloading microSelectron unit (192Ir source) with or without external radiation from November 1994 to May 2000 at the Tata Memorial Hospital. The mean age was 64 years. The mid-third of the esophagus was involved in 38 patients (66%). The group was comprised of 37 previously untreated patients (29 with < or = 50% Karnofsky performance status and old age, 4 with metastatic disease, and 4 with second primary esophageal lesions) and 21 patients with post-treatment recurrent tumors. Thirty-eight patients (65%) received intraluminal brachytherapy alone, whereas the remaining 20 patients (35%) received a combination of external and intraluminal radiation therapy. All patients received 2 fractions of HDR-ILRT 1 week apart with 600 cGy per fraction at 1 cm off axis. RESULTS: Overall improvement in swallowing status was seen in 22 patients (48%), and 24 (41%) maintained pretreatment swallowing status. Median dysphagia-free survival was 10 months. Overall complication rates were 30%, with stricture seen in 9 patients (15%), ulceration in 6 (10%), and tracheo-esophageal fistula in 3 patients (5%). Complication rates were higher in the post-treatment group (38%) than in the previously untreated group (27%) (p = 0.29). The median overall survival for the entire group was 7 months. Median survival was better, although not significantly, for the previously untreated cohort: 7.8 months vs. 6 months for the post-treatment group (p = 0.77). CONCLUSION: HDR-ILRT brachytherapy achieves good palliation with acceptable complications in advanced/recurrent esophageal carcinoma.

Adult↗
PubMed2002

Randomized phase II chemotherapy and radiotherapy trial for patients with locally advanced inoperable non-small-cell lung cancer: long-term follow-up of RTOG 92-04.

PURPOSE: The standard treatment for patients with locally advanced inoperable non-small-cell lung cancer and good prognostic factors has become combined chemotherapy (ChT) and radiotherapy (RT). However, the sequencing of the two modalities, as well as fractionation of RT, has been controversial. The Radiation Therapy Oncology Group (RTOG) Study 92-04 was a randomized Phase II study designed to evaluate further the toxicity and efficacy of 2 different strategies of chemoradiation evaluated in 2 prior RTOG Phase II studies. METHODS: Patients with Stage II or III medically inoperable or unresectable non-small-cell lung cancer, good performance status, and minimal weight loss were enrolled into a prospective randomized Phase II RTOG study. Arm 1 consisted of induction ChT (vinblastine 5 mg/m(2) i.v. bolus weekly for the first 5 weeks, and cisplatin, 100 mg/m(2) i.v. on Days 1 and 29) followed by concurrent ChT/RT (cisplatin 75 mg/m(2) i.v. on Days 50, 71, and 92) during thoracic radiotherapy (63 Gy in 34 fractions during 7 weeks starting on Day 50). Arm 2 was concurrent ChT and hyperfractionated RT starting on Day 1 with a total dose of 69.6 Gy in 58 fractions during 6 weeks, 1.2 Gy/fraction b.i.d. ChT consisted of cisplatin, 50 mg/m(2) i.v. on Days 1 and 8, and oral VP-16, 50 mg b.i.d. for 10 days only on the days of thoracic radiotherapy repeated on Day 29. RESULTS: A total of 168 patients were entered between 1992 and 1994, and 163 patients were eligible for analysis. Eighty-one patients were treated in Arm 1 and 82 patients in Arm 2. Pretreatment characteristics, including age, gender, Karnofsky performance status, histologic features, and stage, were similar. The incidence of acute esophagitis was significantly higher among patients treated in Arm 2 than among those treated in Arm 1 (p <0.0001). The incidence of acute hematologic toxicity was significantly higher among patients treated in Arm 1 (p = 0.01 for anemia and p = 0.03 for other hematologic toxicities) than among those treated in Arm 2. Analysis of late toxicity showed that chronic esophageal toxicity was significantly more frequent in Arm 2 than in Arm 1 (p = 0.003). The time to in-field progression was significantly different (p = 0.009), favoring Arm 2 compared with Arm 1 (26% vs. 45% with failure in 2 years and 30% vs. 49% with failure in 4 years, respectively). The median 2-year and overall 5-year survival rates were similar between the two arms. CONCLUSION: Concurrent ChT and hyperfractionated RT resulted in a significant prolongation of the time to in-field progression, but with higher acute and chronic esophagitis. No other significant differences were observed between the two groups. Investigation with a chemoradio-protector is under way.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1985

Absence of major depressive disorder in female cancer patients.

This investigation evaluated the prevalence of depression in female patients who had cancer in any of five predesignated sites. Five hundred five women aged 17 to 80 (190 with breast cancer, 143 with gynecologic malignancies, 111 with melanoma, 37 with bowel cancer, and 24 with lymphoma) were randomly screened. Assessment included the Hamilton rating scale for depression, the Zung self-rating depression scale, the Karnofsky performance scale, and a 10-cm visual pain analogue line. The results revealed a mean Hamilton of 10.2 (range, 0 to 41; SD, 7.5), a mean Zung score of 35.3 (range, 11 to 68; SD, 9.6), a Karnofsky median score of 80, and a median pain score of 0. Scores on the Zung scale were highly correlated with those of the Hamilton scale (r = .75). Based on cutoff scores accepted as indicating depression (Hamilton greater than or equal to 20 and Zung greater than or equal to 50), patients were depressed. The depressed subgroup was in significantly more pain, experienced greater physical disability, and was more likely to have had prior episodes of depression as compared to the non-depressed women. The two best predictors of current depression were performance status (Karnofsky) and history of depression. No relationship was found between depression and other demographic variables or disease parameters (diagnosis, time since diagnosis, stage or phase of illness, and current treatment). Our findings indicate that the prevalence of major depression in cancer patients is lower than many previous studies have indicated and falls within the range seen in the general population.

Adolescent↗
PubMed2005

Carboplatin plus gemcitabine in patients with inoperable or metastatic pancreatic cancer: a phase II multicenter study by the Hellenic Cooperative Oncology Group.

BACKGROUND: In the present phase II multicenter study, we assessed the efficacy and tolerability of the combination of gemcitabine and carboplatin in patients with advanced pancreatic cancer. PATIENTS AND METHODS: Patients with previously untreated, locally advanced or metastatic pancreatic cancer were treated with gemcitabine 800 mg/m(2) on days 1 and 8 and carboplatin at an AUC of 4 on day 8 of a 3-week cycle, for a total of six cycles. Primary end points were response rate and clinical benefit; secondary end points were, survival, time to progression (TTP) and toxicity. RESULTS: A total of 50 patients were enrolled in the study, 47 of whom were eligible for treatment. The median age was 63 years (range 34-76) and the median Karnofsky performance status (PS) was 80%. Patients received a median of six cycles (range 1-11). Among 35 patients evaluable for response, eight (17%) achieved partial response; 15 (32%) and 12 (25%) patients had stable and progressive disease, respectively. The median overall survival was 7.4 months; the median TTP was 4.4 months and the 1-year survival was 28%. The observed clinical benefit response was remarkable. After the second cycle of chemotherapy, 21 of 31 (68%) patients experienced pain improvement and reduced analgesic consumption. At the same time, 35% and 56% of our patients significantly improved their Karnofsky PS and weight, respectively. Overall, the treatment was well tolerated. The most common grade 3-4 toxicities were hematological, including 8% anemia, 6% neutropenia and 13% thrombocytopenia. CONCLUSIONS: The combination of gemcitabine plus carboplatin is a moderately active treatment for patients with locally advanced and metastatic pancreatic cancer. This regimen has an acceptable toxicity profile and provides a significant clinical benefit, and hence warrants further investigation.

Adult↗
PubMed2005

Patterns of care survey (PCS) in lung cancer: how well does current U.S. practice with chemotherapy in the non-metastatic setting follow the literature?

BACKGROUND: In LD-SCLC, combined modality therapy has emerged as the standard of practice in good performance status (PS) patients (pts). Pignon's meta-analysis [N Engl J Med 1992;327:1618-24] showed that combination chemotherapy (CT) and thoracic radiation (XRT) in LD-SCLC yielded an absolute 5.4% increase in 3-year survival versus chemotherapy alone. Concurrent chemoradiation upfront has generated the highest survival rates [Murray. J Clin Oncol 1993;11:336-44; Jeremic. J Clin Oncol 1996;15:893-900; Takada. J Clin Oncol 2002;20:3054-60]. In stage III NSCLC, multiple studies have shown therapeutic superiority for combination chemotherapy and XRT versus RT alone; and recent literature suggests a therapeutic advantage for concurrent chemoradiation versus chemotherapy followed by XRT [Curran. ASCO 2000;19:484a; Furuse. JCO 1999;17:2692-9; Zatloukal. ASCO 2002;A-1159]. Data are less secure regarding the role of chemotherapy in stage I and II NSCLC. MATERIAL AND METHODS: A stratified two-step cluster sampling technique was used for data collection. Five hundred and forty-one individuals diagnosed between 1998 and 1999 with lung cancer, either LD-SCLC or stages I-III NSCLC were sampled from 58 institutions featuring radiotherapy facilities, giving a weighted sample size (wss) of 42,335 patients. All pts had Karnofski performance status (KPS) >or=60. We determined the percentage who received chemotherapy; the nature of chemotherapy and its timing with respect to XRT. SUDAAN statistical software was used to allow the incorporation of the design elements and weights to reflect the relative contribution of each institution and each patient in the analysis RESULTS: Of 72 (wss=6138) pts with LD-SCLC, 100% received XRT and 95% received chemotherapy (CT); 66% received concurrent (con) CT and XRT, of whom 29% also received CT pre XRT; 22% received CT post XRT as well, and 23% received both: 63% received sequential CT-->XRT+/-con CT; and 38% received some CT after XRT. Fifty-two percent received cisplatin (DDP), and 38% received carboplatin (CBDCA); 73% received etoposide (VP-16), while 10% received paclitaxel. Of 469 pts (wss=36,197) with NSCLC, 52% received CT, including 30% with stage I disease, 48% with stage II NSCLC, 60% with stage III NSCLC, and 50% with unknown stage. Thirty-nine percent received sequential CT-->XRT+/-CT, of whom 49% received CT pre XRT only. Seventy-four percent received con CT and XRT; and 27% received posterior CT, of whom 84% also received con CT/XRT. Forty-five received some CT in the pre-op setting and 15% in the post-op setting. Twelve percent received DDP-based therapy, while only 13% and 7% received VP-16 or vincas, respectively; 67% received CBDCA. Seventy-two percent received taxanes, of whom 96% received paclitaxel. Gemcitabine was administered to 3% of NSCLC pts. CONCLUSIONS: Combined modality therapy is typically employed in the therapy of LD-SCLC and LA-NSCLC. The majority of those treated for SCLC receive concurrent CT/XRT, while nearly 3/4 of those treated with CT and XRT for LA-NSCLC received concurrent CT/XRT. Current practice in the US generally matches evidence-based literature, although a significant percentage of practitioners substitute CBDCA for DDP in both venues and use paclitaxel in lieu of vincas or etoposide in NSCLC.

Adult↗
PubMed2004

Whole brain radiation therapy with or without stereotactic radiosurgery boost for patients with one to three brain metastases: phase III results of the RTOG 9508 randomised trial.

BACKGROUND: Brain metastases occur in up to 40% of all patients with systemic cancer. We aimed to assess whether stereotactic radiosurgery provided any therapeutic benefit in a randomised multi-institutional trial directed by the Radiation Therapy Oncology Group (RTOG). METHODS: Patients with one to three newly diagnosed brain metastases were randomly allocated either whole brain radiation therapy (WBRT) or WBRT followed by stereotactic radiosurgery boost. Patients were stratified by number of metastases and status of extracranial disease. Primary outcome was survival; secondary outcomes were tumour response and local rates, overall intracranial recurrence rates, cause of death, and performance measurements. FINDINGS: From January, 1996, to June, 2001, we enrolled 333 patients from 55 participating RTOG institutions--167 were assigned WBRT and stereotactic radiosurgery and 164 were allocated WBRT alone. Univariate analysis showed that there was a survival advantage in the WBRT and stereotactic radiosurgery group for patients with a single brain metastasis (median survival time 6.5 vs 4.9 months, p=0.0393). Patients in the stereotactic surgery group were more likely to have a stable or improved Karnofsky Performance Status (KPS) score at 6 months' follow-up than were patients allocated WBRT alone (43% vs 27%, respectively; p=0.03). By multivariate analysis, survival improved in patients with an RPA class 1 (p<0.0001) or a favourable histological status (p=0.0121). INTERPRETATION: WBRT and stereotactic boost treatment improved functional autonomy (KPS) for all patients and survival for patients with a single unresectable brain metastasis. WBRT and stereotactic radiosurgery should, therefore, be standard treatment for patients with a single unresectable brain metastasis and considered for patients with two or three brain metastases.

Adult↗
PubMed1997

Superior sulcus tumor (SST): management at the Institute of Oncology in Ljubljana, Slovenia, 1981-1994.

During the 14-year period under study, 48 patients with SST were treated at the Institute of Oncology in Ljubljana, Slovenia. There were 46 males and two females, aged 29-88 years (median, 60 years). Of 37 cytologically or histologically confirmed tumors, 12 were squamous, eight large-cell, one small-cell, eight adeno, and eight unclassified carcinomas. Performance status (Karnofsky) was assessed as > 90 in eight, 70-90 in 31 and < 70 in nine patients. The duration of symptoms before diagnosis ranged from 1 to 36 months (median, 5 months). All patients had pain, while six also had hemophthysis, 14 Horner's syndrome, and four Horner's syndrome and upper limb paresis. Before the first chest X-ray, 19 patients- were treated for shoulder pain by different specialists. Apical tumor infiltration only on the chest X-ray was found in 13, destruction of the ribs in 31, and destruction of the ribs and vertebral bodies in four patients. Treatment was as follows: radiotherapy in 39 patients (22 with radical, 17 with palliative dose), a combination of surgery and radiotherapy in seven, radiotherapy and chemotherapy in one, and symptomatic therapy alone in one patient. One- and four-year survival of all treated patients was 27% and 11%, respectively. One of the seven patients operated on survived for 44 months, and 2/39 irradiated ones survived for 37 and 56 months, respectively, while others died within 24 months from diagnosis. In 81% of patients the pain was subdued after radiotherapy. The disease-specific survival of all patients included in the follow-up correlated with performance status and M stage, while that of those treated by irradiation alone correlated with tumor dose (P < 0.05).

Adult↗
PubMed1998

Anticachectic efficacy of megestrol acetate at different doses and versus placebo in patients with neoplastic cachexia.

Anorexia and cachexia are present in the majority of patients with advanced-stage cancer. Several agents have been tested for their ability to reverse weight loss in these patients. Megestrol acetate has been demonstrated to improve appetite and weight, independent of tumor response, when used in the treatment of metastatic breast cancer. Several trials have studied the ability of megestrol acetate to stimulate weight gain in patients with non-hormone-sensitive tumors. One hundred fifty patients with a weight lost of more than 5% in the 3 previous months were randomized between double-blind megestrol acetate 160 mg daily (LMA), megestrol acetate 480 mg daily (HMA), or placebo (P). Weight, mid-arm circumference, triceps skinfold thickness (TST), performance status (Karnofsky index), and a quality-of-life status by seven linear analogic self-assessment scales were assessed before the start of treatment and at 4, 8, and 12 weeks thereafter. One hundred seven patients were assessable at 4 weeks, 79 at 8 weeks, and 64 at 12 weeks. Sixty-eight percent of patients treated with HMA increased their weights during their permanence on study, versus 37% and 38% of patients treated with P or LMA (p < 0.03). The mean weight gain after 12 weeks of treatment with HMA was 5.41 kg. A significant increase on TST was observed in the HMA group versus the LMA and P groups. There was no gain in performance status or quality of life in any group of treatment. The toxicity registered was mild. There were no thromboembolic events. This trial supports the efficacy of megestrol acetate at 480 mg/day in the treatment of cancer-related cachexia and anorexia, with mild toxicity. However, performance status and quality of life were not influenced by this treatment.

Aged↗
PubMed1990

Quality of life in a placebo-controlled trial of zidovudine in patients with AIDS and AIDS-related complex.

We measured quality of life using the Karnofsky Performance Status and Quality of Well-Being scale (QWB) for 31 patients with AIDS and AIDS-related complex in a placebo-controlled trial of zidovudine. Sixteen patients were randomized to zidovudine and 15 to placebo. We recorded nine scores for each patient during 1 year. During the blinded trial, 3 patients receiving placebo died; at 1 year, one had died in the zidovudine group and 10 in the placebo group. Repeated-measures analysis of variance demonstrated that mean scores declined less for the zidovudine group than for the placebo group during the blinded trial (p less than 0.03) and during 1 year (p less than 0.002). However, because the QWB incorporates death into its score, these results largely reflected differences in mortality. When data from those who died were excluded, Karnofsky scores were higher for the zidovudine group at the end of the blinded trial (p less than 0.02), but at 1 year no significant differences were observed between groups. The QWB and other quality-of-life measures may contribute to more comprehensive evaluation of AIDS treatments, and may detect treatment effects earlier. Whether existing measures can detect real differences among survivors will require testing in patients with less advanced disease.

AIDS-Related Complex↗
PubMed2003

Effect of education level on outcome of patients treated on Radiation Therapy Oncology Group Protocol 90-03.

BACKGROUND: It has been hypothesized that people in lower socioeconomic groups have worse outcomes because they present with advanced-stage cancers or receive inadequate treatment. The authors investigated this hypothesis by using education level as a proxy for socioeconomic status in patients treated on Radiation Therapy Oncology Group (RTOG) Protocol 90-03. METHODS: RTOG 90-03 was a Phase III randomized trial investigating four different radiation fractionation schedules in the treatment of locally advanced head and neck carcinomas. Overall survival and locoregional control rates were analyzed by education level as measured by patient response on the demographic form at study entry. RESULTS: A significant difference was observed in the distribution of patients by education level between the standard fractionated radiation treatment arm and the hyperfractionated radiation treatment arm. More patients in the standard fractionated treatment arm had a higher education level (P = 0.018). Patients attending college had highly and significantly better overall survival and locoregional control than the other groups combined (P = 0.0056 and P = 0.025, respectively: from Cox proportional hazards models stratified by assigned treatment with educational level, T classification, N classification, Karnofsky performance status, primary site, and race). Multivariate analysis revealed that education level was significant for predicting both overall survival and locoregional control when comparing attended college/technical school compared with all other education levels. CONCLUSIONS: Patients attending college or technical school had improved overall survival and locoregional control. These differences cannot be explained by differences in tumor stage or treatment. Poorer overall health or lack of support systems contributing to these results needs to be investigated further.

Adult↗
PubMed1983

Phase II clinical trial of cis-dichlorodiammine platinum (cis-DDP) for antitumorigenic activity in previously untreated patients with metastatic breast cancer.

A phase II clinical trial was set up in metastatic breast cancer patients who had not received previous cytotoxic drug therapy, involving the administration of cis-dichlorodiammine platinum (cis-DDP). Patients aged up to 75 years and with pathohistologically confirmed disease were entered on the trial. All patients had measurable disease, a performance status (Karnofsky) of greater than 40, and an expected survival of greater than 6 weeks. In all 38 patients entered the trial, and 35 have been evaluated. The predominating metastatic sites included soft tissues (19), visceral organs (12), and bones (7 patients). cis-DDP was administered in a daily dose of 30 mg/m2 IV by a 4-h drip for 4 days, with customary hyperhydration. The results indicate a pronounced antitumorigenic effect of cis-DDP and a response rate of 54% (19/35), with 13 complete remissions (37%) and six partial remissions (17%). In terms of site the best response was obtained in soft-tissue processes (13/19; 68%), followed by visceral organs (4/10; 40%); the response rate was lowest in bones (2/6; 33%). The menopausal status and prior hormone therapy did not essentially influence the results of treatment, unlike previous irradiation. Patients with a lower performance status (40-70) had a significantly lower response rate (36% vs 63%; P less than 0.05). Toxic side-effects were moderate and did not substantially affect the general condition of the patients. A transient increase of serum creatinine was observed in 4 patients, and neurotoxicity in 2 patients. The results of the trial warrant the conclusion that cis-DDP has a pronounced antitumorigenic effect in untreated metastatic breast cancer, particularly in soft-tissue metastases. These results call for additional clinical study of the cytotoxic effect of cis-DDP in untreated metastatic breast cancer.

Adult↗
PubMed1990

Ifosfamide and mesna at high doses for the treatment of cancer of the cervix: a GETLAC study.

This study was carried out to assess the efficacy of high-dose ifosfamide/mesna (HDIFM) in the treatment of advanced or recurrent cancer of the cervix. In all, 18/21 evaluable patients with advanced or inoperable cervical cancer were included. The mean age was 42 years (range, 31-58 years); and the International Federation of Gynecology and Obstetrics (FIGO) stage was III in 10 patients and IV in 11. The Karnofsky performance status ranged between 70 and 90, with a median of 77. Ten patients had previously been treated with surgery, radium and cobalt (8) or cobalt alone (2). Therapy consisted of 3.5 g/m2, ifosfamide (IFO) given in an 8-h i.v. infusion on days 1-5 and mesna at 20% of the IFO dose, given i.v. at 0, 2, 4, 6 and 8 h, followed by mesna at 40% of the IFO dose by the oral route at 10 and 12 h on days 1-5. For evaluation purposes, patients received at least two cycles. Toxicity was registered in 137 cycles and was mild to moderate. Three complete (16.6%) and six partial (33.3%) responses were observed (50%), but 66% of them occurred in areas that had not previously been irradiated. The median duration of response was 14 months and the overall median survival was 15+ months (18+ months for responders). The Karnofsky scale after treatment ranged from 90 to 100. The results of this study indicate that HDIFM is well tolerated, giving a high percentage of remission (50%) and significantly improving the quality of life.

Adult↗
PubMed1983

Methotrexate and 5-fluorouracil following tamoxifen and premarin in advanced breast cancer.

Complete remissions in patients with advanced breast cancer using either endocrine therapy or chemotherapy are infrequent. Breast tumors are known to be heterogeneous with respect to estrogen receptor (ER) status, and the low complete remission rate may be secondary to this biochemical heterogeneity. Laboratory experiments using breast cancer cells in long-term tissue culture revealed that tamoxifen is cytotoxic, estrogen stimulates the growth of ER-positive cells and can rescue cells from tamoxifen's effect, and sequential MTX/5-FU is synergistic in rapidly growing breast cancer cells. Based on this, a phase II protocol was designed using tamoxifen, 10 mg p.o. b.i.d. for days 1 to 10. This was followed by Premarin, 0.625 mg p.o. b.i.d., on days 11 to 14. On day 14 the patients were given MTX, 200 mg/m2 i.v., followed in 1 hr by 5-FU, 600 mg/m2 i.v. The patients were rescued with leucovorin, 10 mg/m2 24 hr later. This dose of leucovorin was repeated every 6 hr for six doses. The cycle is repeated every 18 days. Thus far, 35 patients have been entered and 32 are currently evaluable for response. The median age is 57 years. The median Karnofsky performance status was 90. Of the 35 patients, 63% were ER-positive, and 23% had received prior endocrine therapy or chemotherapy; 71% were postmenopausal. One third of the patients had visceral-dominant disease. The overall response rate was 69%; 15 of 32 (47%) attained a complete remission, and 7 of 32 (22%) had a partial remission. Toxicity was minimal. Median nadir white blood cell counts were 5600/cu mm, and median nadir platelet counts were 252,000/cu mm. Nausea and vomiting occurred in 25% of patients, but there was no hair loss, rash, or diarrhea. Mucositis was rare. In summary, this combination hormonal-chemotherapy regimen is highly effective with a high complete remission rate and minimal toxicity.

Adenocarcinoma↗
PubMed1988

Malnutrition and the role of nutritional support for radiation therapy patients.

The nutritional status of a tumor patient can be negatively influenced by the local and systemic effects of the malignant tumor (tumor cachexia, anorexia, difficult oral food intake), by the effects of the various antitumoral therapy modalities (surgery, radiotherapy, chemotherapy), and by the complications associated with such modalities (anorexia, nausea, vomiting, mucositis, xerostomia, alterations of the smell and taste sensations, odynophagia, dysphagia, maldigestion, malabsorption, diarrhea, steatorrhea, conditioned aversions, radiogenic late effects), as well as by the psychological reactions of the patient to the real or feared existence of his tumor. The radiation-induced nutritional disorders depend on the tumor localization, the region irradiated, the dose and length of radiotherapy, the fractionation, the volume irradiated, and the combination with other therapeutic modalities ("combined modality therapy"). The acute radiation-induced reactions are usually of limited duration and for this reason tend to interfere with the nutritional status to a lesser extent than the permanent chronic consequences of irradiation. Weight loss and malnutrition tend to develop particularly in patients in whom segments of the gastrointestinal tract are subjected to irradiation. The incidence and severity of deficient nutrition depend not only on the region irradiated (head-neck region, thorax, abdomen, pelvis) but also, and most particularly, on the volume of the digestive tract irradiated. Chemotherapy and radiotherapy combined act very strongly on rapidly proliferating cell populations (skin, mucosa, epithelium of the gastrointestinal tract). In this context, actinomycin D and adriamycin act like real sensitizers, whereas the majority of the other drugs are likely to produce only an additive effect. The first named cytostatics give rise to the so-called recall phenomenon, i.e., the reactivation of latent radiation effects in response to the subsequent administration of the drug. Malnutrition impairs organ function and ultimately results in increased morbidity and mortality. For this reason it has proven mandatory and reasonable that the organism of all tumor patients suffering from malnutrition is provided with the missing essential nutrients (especially amino acids for protein synthesis). This tends to clearly improve the Karnofsky performance status, with a positive effect on response rates, toxicity, and survival rates in retrospective studies.(ABSTRACT TRUNCATED AT 400 WORDS)

Abdominal Neoplasms↗