Annals of Oncology 2008 19(7):1211; doi:10.1093/annonc/mdn415
© The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org
In this issue
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Premenopausal endocrine-responsive early breast cancer
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For endocrine-responsive breast cancer, the benefit of chemotherapy
is due to a complex mixture of cytotoxic and endocrine mechanisms.
The additional benefit of chemotherapy for premenopausal patients
with endocrine-responsive breast cancer who receive combined
endocrine treatment with ovarian function suppression/ablation
and tamoxifen (or an aromatase inhibitor) remains an open question
that prospective randomized clinical trials (RCTs) have been
unsuccessful in answering, as diverging opinions regarding its
efficacy result in some physicians recommending it while others
do not. The International Breast Cancer Study Group initiated
two concurrent trials in this population: in the Premenopausal
Endocrine Responsive Chemotherapy (PERCHE), chemotherapy use
was determined by randomization and in the Tamoxifen and Exemestane
Trial (TEXT) by physician choice. PERCHE closed with inadequate
accrual; TEXT accrued rapidly. In this issue, Regan et al. (pp.
1231–1241) report an analysis of these trials that explores
patient-related factors according to whether or not chemotherapy
was given using descriptive statistics and classification and
regression trees. These authors report that the perceived estimation
of increased risk of relapse is the primary determinant for
using chemotherapy despite uncertainties regarding the degree
of benefit it offers when added to combined endocrine therapy
in this population.
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XELOX in first-line treatment of metastatic colorectal cancer
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Cetuximab is a monoclonal antibody binding to the epidermal
growth factor receptor (EGFR) with high specificity and a higher
affinity than its natural ligands EGF and transforming growth
factor. Thus, downstream effects of EGFR activation such as
proliferation, angiogenesis or suppression of cell death are
inhibited. Clinical studies in colorectal cancer have shown
cetuximab to induce responses in irinotecan-refractory disease,
but studies comparing cetuximab in the first-line setting in
combination with oxaliplatin and capecitabine have not yet been
published. In this issue, Borner et al. (pp.
1288–1292)
report the results of a randomized phase II trial of adding
cetuximab to first-line oxaliplatin plus capecitabine (XELOX)
for the treatment of patients with metastatic colorectal cancer.
These authors report that differences in response rates between
the treatment arms indicate that cetuximab may improve outcome
with XELOX, but further assessment in phase III trials is required.
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Autologous stem-cell transplantation in relapsed or refractory Hodgkin's lymphoma
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Two prospective randomized analyses of Hodgkin's lymphoma patients
autotransplanted in first relapse show a long-term progression-free
survival advantage especially in those who have relapsed after
a short first complete remission. A meta-analysis including
>2000 patients confirms this. Data from single-center series
and registry data show that
40%–50% patients with relapsed
Hodgkin's lymphoma who have received an autologous stem-cell
transplant (ASCT) are alive after 5 years which is encouraging.
At present there is, however, no refined prognostic information
for the individual patient at the time of ASCT that can be used
to help them and their physician take an informed decision about
the subsequent outcome. In this issue, Sirohi et al. (pp.
1312–1319)
report the results of a study that aimed to assess prognostic
factors and outcome of patients with relapsed/refractory Hodgkin's
lymphoma who received high-dose chemotherapy and ASCT. These
authors report that in addition to previously described prognostic
factors, a Hasenclever index <3 influences outcome favorably
and attaining complete response at ASCT leads to a better outcome.
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Stopping trials early in oncology
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European legislation in pharmaceuticals has been recently revised.
In line with the path of the United States Food and Drug Administration
(FDA), new procedures for granting marketing authorization now
include accelerated and conditional approvals, leading to quicker
access of new drugs to patients. In this issue, however, Trotta
et al. (pp.
1347–1354) report the results of a study that
aimed to assess the use of interim analyses in RCTs testing
new anticancer drugs, focusing on oncological clinical trials
stopped early for benefit. These authors found that out of 14
trials stopped because they had started to show benefit to patients
and published between 2005 and 2007, 11 (79%) were used to support
an application for marketing authorization at the European Medicines
Agency and the United States FDA. The authors indicate that
the relation between sparing patients and saving time and trial
costs indicates that there is a market-driven intent. They indicate
that only untruncated trials can provide a full level of evidence
which can be translated into clinical practice without further
confirmatory trials.
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Quote
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‘Was it a fact? Some people called it rumor. But in fact
there was no such thing as rumor. There was fact, and there
was what did not come up in conversation. Breast cancer was
controllable if caught in the early stages but Lynn may have
waited too long.’
A failure of communication among advertisers considered in Then we came to the end by Joshua Ferris.
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Related articles in Ann Oncol:
- Premenopausal endocrine-responsive early breast cancer: who receives chemotherapy?
- M. M. Regan, O. Pagani, B. Walley, R. Torrisi, E. A. Perez, P. Francis, G. F. Fleming, K. N. Price, B. Thürlimann, R. Maibach, M. Castiglione-Gertsch, A. S. Coates, A. Goldhirsch, R. D. Gelber, and for the SOFT/TEXT/PERCHE Steering Committee and the International Breast Cancer Study Group
Ann Oncol 2008 19: 1231-1241.
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- Adding cetuximab to capecitabine plus oxaliplatin (XELOX) in first-line treatment of metastatic colorectal cancer: a randomized phase II trial of the Swiss Group for Clinical Cancer Research SAKK
- M. Borner, D. Koeberle, R. Von Moos, P. Saletti, D. Rauch, V. Hess, A. Trojan, D. Helbling, B. Pestalozzi, C. Caspar, T. Ruhstaller, A. Roth, A. Kappeler, D. Dietrich, D. Lanz, W. Mingrone, and for the Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland
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Ann Oncol 2008 19: 1312-1319.
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Ann Oncol 2008 19: 1347-1353.
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