John C. Ruckdeschel

Information and decision-making preferences of hospitalized adult cancer patients.

Physician behaviors and patient responses were studied in 439 interactions between hospitalized adult cancer patients and oncologists to investigate patient preferences for a participatory role in the interaction. Patients were asked their preference for information to be given (minimal; only if it is good news; or all information, good or bad) and their preference for participation in decision-making (prefer doctor makes therapeutic decisions or prefer to participate in decisions). The majority (92%) preferred all information be given, but only 69% preferred to participate in therapeutic decisions. Of those wanting all the information, 24.9% preferred the physician to make the therapeutic decisions. This group was comprised primarily of older, sicker males. Those who did not want to participate were also slightly more satisfied (P less than 0.05). These data suggest that, although most patients prefer all information to be given to them, almost one-fourth of them preferred a more authoritarian, rather than participatory, relationship with their oncologist.

A randomized trial of the four most active regimens for metastatic non-small-cell lung cancer.

Between October 1981 and June 1983, the Eastern Cooperative Oncology Group (ECOG) conducted a prospectively randomized trial (EST 1581) of the four most active chemotherapy regimens for metastatic non-small-cell lung cancer (NSCLC). Four hundred eighty-six good performance status patients (PS 0 or 1; 81%) were randomized to receive cyclophosphamide, doxorubicin, methotrexate, and procarbazine (CAMP); mitomycin, vinblastine, and cisplatin (MVP); etoposide and cisplatin (VP-P); or vindesine and cisplatin (VDA-P). All regimens were administered in the doses and schedules originally reported. Complete response (CR) plus partial response (PR) rates for the four regimens were CAMP, 17%; MVP, 31%; VP-P, 20%; and VDA-P, 25%. The response rate for MVP was significantly higher in patients with squamous and adenocarcinoma histologies, but there was no impact on median survival (overall, 24.5 weeks). The duration of response did not differ by treatment as previously suggested for VDA-P. There were 15 CRs (CAMP, one; MVP, six; VP-P, two; VDA-P, six), and 12 patients have survived more than 2 years. Toxicity was significant with 20 treatment-related deaths. CAMP was significantly less toxic than the other regimens (P less than .001). VDA-P demonstrated significantly more life-threatening (seven) and lethal (three) episodes of nephrotoxicity (P less than .001) despite an aggressive hydration program that in itself caused significant morbidity. Analysis of the toxicity data showed, however, that most of the severe toxicity occurred in the 19% of patients who were initially PS 2, suggesting that they are not appropriate candidates for trials of new agents or combinations. None of these regimens can be recommended as a standard therapy for metastatic NSCLC.

Combination chemotherapy versus single agents followed by combination chemotherapy in stage IV non-small-cell lung cancer: a study of the Eastern Cooperative Oncology Group.

During the last decade, the Eastern Cooperative Oncology Group (ECOG) has studied a series of combination chemotherapy regimens in metastatic (stage IV) non-small-cell lung cancer (NSCLC). In January 1984, the ECOG activated a randomized study, EST 1583, which concluded the evaluation of combination regimens in phase III trials and initiated the evaluation of single agents exclusively in previously untreated patients. The treatment regimens in EST 1583 consisted of: (1) mitomycin, vinblastine, and cisplatin (MVP); (2) vinblastine and cisplatin (VP); (3) MVP alternating with the regimen cyclophosphamide, doxorubicin, methotrexate, and procarbazine (CAMP); (4) carboplatin followed by the MVP regimen at the time of progression; and (5) iproplatin followed by MVP at the time of progression. From January 1984 to July 1985, 743 patients were entered on this trial and 699 fulfilled the eligibility requirements. The following objective response rates (complete plus partial remissions) were observed: first-line MVP, 20%; VP, 13%; MVP/CAMP, 13%; carboplatin, 9%; iproplatin, 6%; and second-line MVP, 6%. First-line MVP produced a significantly higher response rate than the other treatments (P = .03) adjusted for prognostic variables. Using analyses that were adjusted for prognostic covariates, survival for patients treated on a given regimen was compared with survival for all remaining patients. These analyses showed that treatment with carboplatin was associated with longer survival (median survival time, 31.7 weeks; P = .008) while initial treatment with MVP was associated with a trend for shorter survival (median survival time, 22.7 weeks; P = .09). It should be noted that none of these regimens appear to have produced a clinically meaningful prolongation of survival. Similar analyses evaluating time to progression disclosed that carboplatin-treated patients had a significantly longer time to progression (median time to progression, 29 weeks) than all remaining patients (P = .01). Life-threatening and lethal toxicities (toxicity grades 4 and 5) were greater on the combination regimens than on the single agents (P less than .0001). Based on these results, current group-wide ECOG trials in stage IV NSCLC consist of randomized phase II trials evaluating single agents.

Long-term survivors in metastatic non-small-cell lung cancer: an Eastern Cooperative Oncology Group Study.

Between December 1979 and June 1983 the Eastern Cooperative Oncology Group (ECOG) treated 893 good-performance status patients with metastatic non-small-cell lung cancer (NSCLC) on one of seven phase III combination chemotherapies. The overall median survival was 23.5 weeks with no significant differences between treatments. One hundred sixty-eight patients (19%) survived greater than 1 year and 36 (4%) for greater than 2 years. The etoposide-platinum combination had the highest proportion of 1-year survivors (25%). Mitomycin-vinblastine-platinum (MVP), which had demonstrated the highest response rate, had significantly fewer 1-year survivors (12%) than any other regimen (P = .003). Analysis of pretreatment characteristics that distinguished patients who survived greater than 1 year from those who did not demonstrated that an initial performance status of 0, no bone metastases, female sex, no subcutaneous metastases, non-large-cell histology, less than 5% prior weight loss, no symptoms of shoulder or arm pain, and no liver metastases were predictors of longer survival. Of particular interest was the finding that response duration was significantly longer (P = .002) for those patients who experienced a longer time to best response. In addition, patients who survived greater than 1 year experienced greater degrees of nonlethal toxicity, in particular, gastrointestinal and hematologic, than patients who did not survive 1 year, (P = .006). A detailed chart review of 32 2-year survivors and 32 matched controls demonstrated that maintenance or improvement of performance status and maintenance of serum albumin levels at 3 months from the initiation of treatment were both important predictors of longer survival.

The multidimensional nature of cancer-related pain

Abstract A critical review of the literature examining the assessment of cancer‐related pain revealed a lack of systematic research. In the present study, 40 patients with cancer‐related pain were compared to 37 pain‐free cancer patients matched on diagnosis, stage of disease, age, sex, and inpatient vs. outpatient status. The results supported a multidimensional conceptualization of cancer‐related pain consisting of sensory, affective, cognitive, and behavioral components.

Randomized prospective comparison of intraventricular methotrexate and thiotepa in patients with previously untreated neoplastic meningitis. Eastern Cooperative Oncology Group.

PURPOSE This prospective randomized cooperative group study was conducted in patients with neoplastic meningitis treated with intrathecal methotrexate or thiotepa to assess response rates and survival, prognostic factors, and the toxicity of these regimens. PATIENTS AND METHODS Fifty-nine adults with nonleukemic malignancies, performance status of 0 to 3, and positive CSF cytologies were assigned to receive intrathecal methotrexate (10 mg) or thiotepa (10 mg) twice weekly. Radiation, was administered to mass lesions and/or symptomatic sites and appropriate systemic therapy was given concomitantly. RESULTS Fifty-two patients were assessable. Most were female (79%), nonambulatory (77%), had been pretreated with radiation (52%) and chemotherapy (77%), and had evidence of systemic disease (65%). Most primary cancers were of the breast (48%), lung (23%), or lymphatics (19%). Treatment arms were well balanced, except that more patients randomized to methotrexate had breast cancer (61% v 33%) and were without evidence of systemic cancer (21% v 4%). No patient had important neurologic improvement with therapy, and 75% deteriorated neurologically within 8 weeks of initiating therapy. Survival ranged from 4 days to 110.5+ weeks. Median survival for patients receiving methotrexate was 15.9 weeks and 14.1 weeks for patients treated with thiotepa. Factors predictive of shorter survival included progressive systemic disease (P = .0005), poor performance status (P = .03), and significant cranial nerve palsies (P = .02). Although serious toxicities were similar, mucositis (P = .04) and neurologic complications (P = .008) were more common in patients who received methotrexate. CONCLUSION The efficacy and overall toxicities of intraventricular methotrexate and thiotepa seem similar and neither reverses fixed neurologic deficits. Early diagnosis and treatment and new therapeutic approaches are needed to improve the outcome for patients with neoplastic meningitis.

Efficacy and Costs of Two Forms of Stress Management Training for Cancer Patients Undergoing Chemotherapy

PURPOSE Professionally administered psychosocial interventions have been shown to improve the quality of life of cancer patients undergoing chemotherapy. The present study sought to improve access to psychosocial interventions during chemotherapy treatment by evaluating the efficacy and costs of a patient self-administered form of stress management training that requires limited professional time or experience to deliver. PATIENTS AND METHODS Four hundred eleven patients about to start chemotherapy were randomly assigned to receive usual psychosocial care only, a professionally administered form of stress management training, or a patient self-administered form of stress management training. Quality-of-life assessments were conducted before randomization and before the second, third, and fourth treatment cycles. Intervention costs were estimated from both payer and societal perspectives. RESULTS Compared with patients who received usual care only, patients receiving the self-administered intervention reported significantly (P < or = .05) better physical functioning, greater vitality, fewer role limitations because of emotional problems, and better mental health. In contrast, patients who received the professionally administered intervention fared no better in terms of quality of life than patients receiving usual care only. Costs of the self-administered intervention were estimated to be 66% (from a payer perspective) to 68% (from a societal perspective) less than the average costs of professionally administered psychosocial interventions for patients starting chemotherapy. CONCLUSION Evidence regarding the efficacy and favorable costs of self-administered stress management training suggests that this intervention has the potential to greatly improve patient access to psychosocial intervention during chemotherapy treatment.

Physician behaviors, patient perceptions, and patient characteristics as predictors of satisfaction of hospitalized adult cancer patients

To examine potential predictors of cancer patient satisfaction with physician behavior, 366 cases were studied. Physician behavior was measured on morning rounds using the Physician Behavior Check List (PBCL). Patient satisfaction and perceptions were assessed after the visit. Patient characteristics were obtained from the chart and the physician. Results showed wide variation in physician behavior; no “standard” set of behaviors was seen in all interactions. Patient satisfaction was high (x̌=87.8 mm on a 100‐mm scale). Path analysis showed four variables predicted 62% of the variance in patient satisfaction. The strongest predictor was the patient perception item, “perception of needs addressed that day.” Other predictors were perception of emotional support provided by the physician, age (older), and one physician behavior, “discusses treatment.” Patient perceptions of needs met or emotional support provided were predicted by perceptions of the occurrence of physician behaviors involving information such as the diagnosis and tests and treatment. Overall, patient perceptions of physician behaviors were stronger predictors of patient satisfaction than the actual occurrence or absence of those behaviors.

Postoperative empyema improves survival in lung cancer. Documentation and analysis of a natural experiment.

Abstract A retrospective chart study revealed improved survival rates in patients in whom empyema developed after surgical resection for carcinoma of the lung. The overall five-year survival rate for the empyema group of 18 patients was 50 per cent, compared to an 18 per cent five-year survival rate in a control group consisting of a random 34-patient sample of resected cases at this institution. On further analysis, the beneficial effect of intrapleural infection was found principally in patients with tumor limited to the lung and its draining regional lymph nodes. Six of seven patients in this group survived for five years. The protection from recurrent cancer conferred on these patients by postoperative empyema may have been mediated by the activation of regional cellular immune mechanisms. The reaction between immune lymphocytes and bacterial antigens is believed to release lymphokines and activate macrophages that nonspecifically destroy residual tumor cells while containing the intrapleural infection.

Recombinant Human Erythropoietin in the Treatment of Anemia Associated with Human Immunodeficiency Virus (HIV) Infection and Zidovudine Therapy: Overview of Four Clinical Trials

OBJECTIVE To assess the effect of recombinant human erythropoietin (r-HuEPO) on anemia in patients with the acquired immunodeficiency syndrome (AIDS) who are receiving zidovudine therapy. DESIGN Combined analysis of four 12-week, randomized, double-blind, controlled clinical trials. SETTING Multiple centers in the United States. PATIENTS Two hundred and ninety-seven anemic (hematocrit < 30%) patients with AIDS who were receiving zidovudine therapy. Of the 297 patients, 255 were evaluable for efficacy, but all patients were included in analysis of safety. INTERVENTION Patients were randomly assigned to receive either r-HuEPO (100 to 200 U/kg body weight) or placebo, intravenously or subcutaneously, three times per week for up to 12 weeks. MEASUREMENTS Changes in mean hematocrit, transfusion requirement, and quality of life. RESULTS Sixty-nine percent of patients had endogenous serum erythropoietin levels less than or equal to 500 IU/L, and 31% had erythropoietin levels greater than 500 IU/L. In patients with low erythropoietin levels (< or equal to 500 IU/l), r-HuEPO therapy decreased the mean number of units of blood transfused per patient when compared with placebo (3.2 units and 5.3 units, respectively; P = 0.003) and increased the mean hematocrit from the baseline level (4.6 percentage points and 0.5 percentage points, respectively; P <0.001). Overall quality of life improved in patients on r-HuEPO therapy (P = 0.13). Patients with erythropoietin levels greater than 500 IU/L showed no benefit from r-HuEPO in any outcome variable. Placebo and r-HuEPO recipients did not differ in the incidence of adverse effects or opportunistic infections. CONCLUSION Therapy with r-HuEPO can increase the mean hematocrit and decrease the mean transfusion requirement in anemic patients with AIDS who are receiving zidovudine and have endogenous low erythropoietin levels (< or equal to 500 IU/L). Such therapy is of no apparent benefit in patients whose endogenous erythropoietin levels are higher than 500 IU/L.