GLOBAL CANCER POLICY-MAKING
OVERCOMING CHALLENGES
IN CONDUCTING CLINICAL
TRIALS IN AFRICA
MELISSA ADDE AND IAN MAGRATH, INTERNATIONAL NETWORK FOR CANCER RESEARCH
AND TREATMENT, BRUSSELS, BELGIUM
The African Burkitt Lymphoma Strategy Group of the International Network for Cancer
Treatment and Research (INCTR) recently published the results of the first 356 patients
treated according to a uniform clinical research protocol (INCTR 03-06) from 2004
through the end of 20091.
B
urkitt lymphoma (BL) is one of the commonest to conduct clinical research in Africa.
childhood cancers in equatorial Africa and one that
can be cured with chemotherapy alone2,3. With the Challenges identified
overall objective being to improve the survival of children with The importance of an accurate diagnosis
BL, the Principal Investigators (PIs) representing four In the earlier years of the protocol, the majority of diagnoses
institutions – the Ocean Road Cancer Institute (ORCI) in were made by fine needle aspirate (FNA). Institutions were
Tanzania, the Kenyatta National Hospital (KNH) in Kenya and unable to routinely perform more sophisticated analyses
the Obafemi Awolowo University Teaching Hospitals Complex of diagnostic specimens such as immunohistochemistry (IHC)
(OAUTHC) and the University College Hospital (UCH) Ibadan to rule out other malignancies and cytology alone was used to
in Nigeria – together with INCTR personnel – treatment was make the diagnosis. In a systematic central review of many of
standardized among the four centres and it was agreed, to the FNA specimens by a panel of expert haematopathologists,
collect detailed information about clinical presentation who are part of INCTR’s Pathology Programme, it was learned
features of patients with BL, and to make a determined effort that it was possible to confirm the diagnoses in the majority of
to document treatment effects and outcomes. This led to the cases, but that some specimens were of such poor quality (or
design of the study entitled, “The Treatment and did not even include tumour cells) that the diagnosis could not
Characterization of BL in Africa”. be confirmed4,5. Because not all samples were reviewed, as
Since the time of the initial report, the group has expanded indicated in the recent publication of the data for the initial 356
to three new centres, the St Mary’s Hospital, Lacor in Uganda patients, some patients may not have had BL and therefore,
(2010), the Bugando Medical Centre (BMC) in Tanzania may have increased the number of patients listed as “treatment
(2011) and the Vanga Hospital in the Democratic Republic of failure”. We know this because when patients did not respond
Congo (DRC) (2011) and an additional 269 patients have been to treatment, they underwent tru-cut needle biopsies of tumour
enrolled on the study. In all, and a total of 625 patients have sites. Fifteen of the 625 patients had other malignancies
been enrolled as of the end of December 2012. when re-reviewed by the treating institution or reviewed by
Once the study was underway and patient accrual began, outside institutions. Review diagnoses included acute
many challenges encountered by the sites emerged. These lymphoblastic leukemia, lymphoblastic lymphoma, Hodgkin’s
related to the diagnosis, staging, treatment and follow up of lymphoma, nasopharyngeal carcinoma, neuroblastoma,
patients, the ability to perform protocol-related procedures, rhabdomyosarcoma and carcinomas not otherwise specified. It
and the social circumstances of the children and their families. is important to point out that not all samples, particularly from
Many strategies were put into place to overcome these the newer institutions, have been centrally reviewed and
challenges and we continue to learn how to improve the ability improved diagnosis is likely, therefore, would give a more
CANCER CONTROL 2013 27