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Background. Since most advanced cancers are still incurable, oncologic clinical research pays considerable attention to palliation, increasingly valuing subjective measures of outcome such as quality of life (QoL). We reviewed randomised clinical trials (RCT) of cytotoxic or hormonal treatments in advanced breast cancer (ABC), published before December 2003, to evaluate the methodological quality of QoL assessment and assess its added value (over classical clinical endpoints (CCE), i.e. survival, response, time to progression, toxicity) in the choice of the best treatment option. Methods. RCTs were classified according to treatment characteristics and the CCEs. A descriptive analysis was based on the methodological aspects of QoL assessment and the clinical value of QoL findings was judged by counting the frequency of reporting in the study abstracts and the assessment of QoL combined with CCEs. Results. We retrieved 33 eligible RCTs (10,791 patients); only 20 reported the number of patients considered in QoL principal analysis and only 69% of randomized patients were included in such analyses. A total of 17 different QoL questionnaires were used, 11 only once. QoL assessment lasted from less than 12 weeks to progression, and timing of questionnaires from 2 to 12 weeks. Compliance rates were 85.7% for baseline forms and 67% for overall assessment, but this information was available for only 18 and 20 trials, respectively. Wide variability emerged in analysis strategies and statistical approaches. QoL findings were reported in 12 study abstracts (37% of patients). Eight studies reported a significant difference in QoL scores but since QoL data often failed to parallel the clinical findings (e.g. better QoL scores were reported in two of 17 trials with better CCEs and in six of 20 with significant differences in toxicity profiles), the QoL added value was difficult to ascertain and, on the whole, only moderate. Conclusion. In ABC trials, QoL assessment added relatively little value to CCEs in helping select the best treatment option, apparently largely because of sub-optimal methodological standards.

Over the last ten years the Italian National Research Council (C.N.R.) has launched an educational program aimed at favoring the delivery of the most up to date care for cancer patients in community hospitals. Among various tumors for which this effort was undertaken, management guidelines for colorectal cancer were developed in 1978 by a multidisciplinary team of national experts and reported in booklets distributed nationwide under the aegis of the Colorectal Cancer Task Force. In 1988, the C.N.R. funded an evaluation to learn whether: a) the guidelines were widely diffused in the target physician populations; b) their content was accepted by those who received them and, c) practice patterns were consistent with the recommendations in the guidelines. Overall results indicate only a limited effect. Despite clear evidence of a positive self-selection in the physicians' survey, guidelines were familiar to only 47% of responders. Although acceptance of at least some specific recommendations was good among doctors aware of the guidelines (greater than or equal to 60% responders), this finding loses relevance since a not negligible proportion of those not aware of them had the same convictions. Finally, analysis of practice patterns showed serious deficiencies (mostly in terms of thoroughness of operative staging) even in centers where more widespread knowledge of the guidelines should have led to better quality of care. The paper also discusses the comparability of our findings to results of a similar evaluation carried out in the U.S.A. Our results underscore the importance of analyzing the process of diffusion in any assessment of interventions based on knowledge dissemination.

Patients’ assessment of quality of care was investigated in 825 women with breast cancer treated in a group of specialized and non-specialized institutions in Italy. A 10-page mail questionnaire explored patients’ adjustment to the disease, satisfaction with care, and quality of the information on diagnosis and treatment. Most of the 428 (52 %) responders reported good or acceptable adjustment to the disease (as reflected by acceptable performance in some daily living activities), and favorable judgment about care providers, but many women complained of hospital organizational deficiencies. A contradictory picture emerged regarding the quality of information. Completeness and thoroughness appeared seriously deficient when examined objectively using a series of explicit predefined criteria, but patients’ assessments showed in most cases moderate or high satisfaction. The paper presents these results and discusses pros and cons in the use of patients’ opinions for evaluation of quality of care.

Chemotherapy using cyclophosphamide, doxorubicin, etoposide, cytarabine, bleomycin, vincristine, methotrexate with leucovorin, and prednisone (ProMACE-CytaBOM) for patients with intermediate or high grade non-Hodgkin lymphomas (G, H and K according to the Working Formulation), was tested by the Gruppo Cooperativo Lombardo to confirm the activity of the regimen and to test the feasibility and safety of administering third-generation drug regimen in a cooperative group setting. Among 64 previously untreated patients, aged between 20 and 71 years, 7 had stage IB-IIB, 12 had stage IIIA-B, 45 (67%) had stage IVA-B. There were 44 complete remissions (CRs) (69%) and 14 partial remissions (22%); the difference between patients in stage I-II-III (84% complete remissions) and those in stage IV (62% complete remissions) was statistically significant. The median length of follow up was 20 months (range 1-60 months), with 56% of patients alive at 60 months and 53% of CRs patients free of disease at 60 months. Patients in stage I-II-III have the best survival and disease free survival compared to stage IV, 87% versus 42% and 72% versus 32% respectively (both with high statistical significance). Grade 3-4 (WHO) haematological toxicity was observed in 39% of patients, with 3 septic deaths. Two more patients died with chemotherapy related toxicity (1 stroke and 1 acute renal insufficiency). Administration of ProMACE-CytaBOM is a feasible and safe regimen although it presents moderate toxicity. ProMACE-CytaBOM may represent improved treatment for aggressive lymphomas, in terms of duration of response and survival, but a longer follow up is needed.

We reviewed care delivered to about 2,500 breast cancer patients in general hospitals over the period 1979-1987 using data from three surveys. The most important and consistent failure was in diagnostic timeliness: about one out of four patients was diagnosed six or more months after the first symptom leading to an almost doubled probability of being diagnosed with more advanced disease. Acceptance of treatment recommendations seemed less satisfactory for surgery than for adjuvant treatments. Conservative surgery still appeared to have limited acceptance for patients with small primary tumor (21 and 23% in 1983 and 1987, respectively) although, starting 1983, there was a shift from the Halsted to the Patey type of radical mastectomy. Follow-up was routine in most node-negative patients and adjuvant chemotherapy was already well established treatment for most pre-menopausal node-positive women (64, 79 and 76% in 1979, 1983 and 1987, respectively). Some form of adjuvant treatment in postmenopausal node-positive women was already present In 1983 but became more widespread in 1987 (82%): this being mostly accounted for by the increase in the use of tamoxifen (delivered alone or in combination with chemotherapy to 53% of women). Overall, our results suggest that areas of care more dependent on organization or doctors’ and patients’ education (i.e. diagnostic timeliness and accessibility) are those where deficiencies seen to be least amenable to change in the absence of concerted intervention. Among more narrowly defined clinical issues, there appeared to be some dissonance between the rapid acceptance of adjuvant treatments and the still slow pace of acceptance of less aggressive procedures by surgeons.