Group psychotherapy for recently diagnosed breast cancer patients: a multicenter feasibility study.

As many as 80% of breast cancer patients report significant distress during initial treatment, yet there is little in the way of systematic psychotherapeutic interventions for women coping with the stress of a recent diagnosis of breast cancer. The literature on psychotherapeutic treatment of cancer patients provides uniform evidence for an improvement in mood, coping and adjustment as a result of group therapy. The present study examined the feasibility of implementing a manualized treatment, supportive-expressive group psychotherapy, in busy oncology practices across the US. This intervention was applied to women with primary breast cancer in a manner which tests not only the efficacy of the approach but also its accessibility to group therapists not previously experienced in its use. One hundred and eleven breast cancer patients within 1 year of diagnosis were recruited from ten geographically diverse sites of the National Cancer Institute's Community Clinical Oncology Program (CCOP) and two academic medical centers. Two therapists from each site were trained in supportive-expressive group psychotherapy. Training consisted of participation in a workshop, reading a treatment manual, and viewing explanatory videotapes. Each patient participated in a supportive-expressive group that met for 12 weekly sessions lasting 90 min. Assessment of mood disturbance was made at entry, 3, 6, and 12 months. Results indicated a significant 40% decrease in the Total Mood Disturbance (TMD) scores of the Profile of Mood States (POMS) (ANOVA F [2,174]=3.98, p<0.05). The total symptom score of the Hospital Anxiety and Depression Scale (HADS) was likewise significantly reduced over the 6-month period (F [2, 174]=5.2, p<0.01). Similarly, the total score of the Impact of Event Scale (IES) was significantly reduced (F [2,174]=4.0, p<0.05). There was substantial uniformity of treatment effect across sites. Outcome was independent of stage of disease (I vs. II). We conclude that this treatment program can be effectively implemented in a community setting and results in reduced distress among breast cancer patients.

Justification for evaluating new anticancer drugs in selected untreated patients with extensive-stage small-cell lung cancer: an Eastern Cooperative Oncology Group randomized study.

BACKGROUND: Studies have shown that response to a given chemotherapy in previously untreated patients with extensive-stage small-cell lung cancer is superior to that in patients previously treated with other regimens. This finding raises the question of whether it is necessary and ethical to study the effects of new anticancer agents in untreated patients. Such studies appear to be the best test for drug development, but there has been no evaluation of whether survival of untreated patients, whose cancer is sensitive to established drugs, is adversely affected in trials of new drugs. PURPOSE: This randomized study of untreated patients with extensive-stage small-cell lung cancer was designed (a) to compare the survival of patients treated with either effective standard chemotherapy or an investigational anticancer drug as initial therapy and (b) to evaluate response rates and toxic effects of such therapies. METHODS: Eighty-six patients were randomly assigned to receive, as initial therapy, either the standard CAV regimen--cyclophosphamide (1000 mg/m2), doxorubicin (50 mg/m2), and vincristine (1.4 mg/m2) every 3 weeks--or the phase II drug menogaril (200 mg/m2) every 4 weeks. Treatment after induction therapy varied, depending on patient response, but nonresponders and those with disease progression received salvage chemotherapy--etoposide (120 mg/m2 on days 1, 2, and 3) and cisplatin (60 mg/m2 on day 1), repeated every 3 weeks. RESULTS: Of the 43 patients on CAV, 42% responded (eight complete responses and 10 partial responses); 5% of the 43 on menogaril responded (two partial responses) (P = .0001). Twelve (22%) of 54 patients responded to salvage chemotherapy (five complete responses and seven partial responses). Within 3 months from start of treatment, twelve patients died--3 patients in the CAV group and nine patients in the menogaril group (P = .12). The estimated median survival was 37 weeks with menogaril and 45 weeks with CAV (P = .28). At 6 months, survival was 76.7% for the CAV group and 67.4% for the menogaril group. At 12 months, survival rates were 24.4% and 27.9%, respectively. Confidence intervals (95%) for the differences between the proportions surviving in the two groups were -9%-28% at 6 months and -25%-14% at 12 months. Use of CAV resulted in significantly higher occurrence of severe and life-threatening treatment-related complications (P = .002). CONCLUSION: The confidence intervals for the differences in survival are too wide to conclude that evaluation of a new drug in untreated patients with extensive-stage small-cell lung cancer is or is not harmful. The data do suggest, however, that use of this study design may have no adverse effect on survival.

A phase II trial of intermittent leukocyte interferon and high dose chlorambucil in the treatment of non-Hodgkin's lymphoma resistant to conventional therapy.

Thirteen patients with advanced non-Hodgkin's lymphoma who previously failed conventional chemotherapy protocols were treated with a combination of alpha-interferon (IFN) 6,000,000 units i.m. days 1-5 and 8, plus chlorambucil (CLB) 16 mg/m2 days 5-9 repeated every 4 weeks. There were five complete responses (CRs) and one partial response (PR) (46% total responses) with mean duration of remission of 456+ days. Responses were obtained in low and intermediate grade lymphomas. Toxicity was acceptable and easily managed. It is unlikely that IFN alone using this low dose intermittent schedule is responsible for the remissions. The combination of the two agents appears to be an effective treatment modality. IFN may be functioning as a biological response modifier when used in combination with a cytotoxic agent.

Cisplatin and 5-FU infusion chemotherapy in advanced, recurrent cancer of the head and neck: an Eastern Cooperative Oncology Group Pilot Study.

Thirty-four patients with advanced, recurrent head and neck cancer were treated with cisplatin (100 mg/m2 on Day 1) and continuous-infusion 5-FU (1.0 g/m2/24 hours on Days 1-5) every 3-4 weeks. All but one patient had failed prior radiation therapy or surgery; 27 had failed both. Two patients were not evaluable for response because of death within the first 2 weeks from unrelated heart disease. Among 30 patients with squamous cell carcinoma, five achieved complete response (CR) (17%) and 13 achieved partial response (PR) (43%). Durations of response for patients with a CR and PR were 10.4 and 3.1 months, respectively. Median time to disease progression for all patients was 4.5 months and median survival was 9.1 months. Median survival times for all responders and for complete responders and partial responders were 12.5, 14.2, and 10 months, respectively. One additional patient with an adenocarcinoma failed to respond, while a second with an adenoid cystic carcinoma achieved a PR for 3.4 months. Toxicity was moderate: seven patients experienced Eastern Cooperative Oncology Group grade 3 mucositis, and 11 patients had grade 3-4 hematologic toxicity. There was one treatment-related death due to nephrotoxicity. This study supports other studies that show a relatively high degree of activity of cisplatin and continuous-infusion 5-FU in advanced head and neck cancer.

Comparison of data elements in guidelines developed independently in community hospital oncology programs.

In summary we would like to thank the communities that participated in this study. A comparison of data elements in the guidelines developed by these communities demonstrated similarity in areas of diagnosis, pretreatment evaluation and staging. In the area of treatment it was apparent that physicians writing these guidelines were less autocratic in that more flexibility, more options and less specificity in recommendations was found. That this is not necessarily unfavorable is reflected in the fact that variations existed where the cancer literature is unsettled.