Review for 10.1186/1471-230X-13-125 (2013)

Reviewer's report
Title:Interventionally implanted port catheter systems for hepatic arterial infusion
of chemotherapy in patients with primary liver cancer: A phase II-study.
Version: 2Date:29 July 2013
Reviewer: Robert Martin
Reviewer's report:
INTERVENTIONALLY IMPLANTED PORT CATHETER SYSTEMS
FOR HEPATIC ARTERIAL INFUSION CHEMOTHERAPY IN
PATIENTS WITH PRIMARY LIVER CANCER – PHASE II STUDY
By Sin, et al
This is a re-submission by Sin and colleagues of their innovative highly technical
hepatic arterial infusion chemotherapy catheter placement through a
percutaneous approach. They enrolled 70 patients, 33 with hepatocellular
carcinoma and 37 with intrahepatic cholangiocarcinoma who had been heavily
pre-treated with various forms of standard-of-care treatments and treated them
with intra-arterial Oxaliplatin and 5FU. They have answered a majority of all of
the critiques and suggestions appropriately; however, there are still two major
concerns that need to be addressed by the authors.
First, within the Results section they report that patients received a median of six
chemotherapy applications with a median duration of 3.9 months. They report
what they can do in the ability to administer chemotherapy; however, they do not
provide any information on patients to whom they should do this on. It would be a
reasonable estimation that any patients who are not able to receive at least four
or potentially even six hepatic arterial infusions are not going to receive benefit
from this innovative regional therapy. However, the authors must present the
subset of patients who failed to receive that minimum threshold so that
perspective readers can identify who should not be treated either because of
disease biology or because of anatomic variation that would lead to a greater
incidence of a catheter malfunction before an adequate amount of either four or
six chemotherapeutic applications can be presented. Thus, within the Results the
authors should present a greater degree of granularity of a subset of patients that
received at least six or more or that subset of patients that received four or less.
Again, within the Discussion the authors continue to demonstrate their
institutional bias and over zealous in their presentation as they mentioned within
the second paragraph of their Discussion in that the overall survival and failure of
this therapy was predominantly related to disease progression which preceded
port failure. The authors present this as not being related to port malfunction;
however, the reader evaluates this as the ultimate poor patient selection. Thus,
again, if the authors claim that this therapy is indeed potentially effective they
must present the true subset who will get a potential benefit since coming to a
regional center and being infused even with regional chemotherapy every two
weeks is a significant quality-of-life interruption and if the patient is not going to
get benefit defined as an improvement in quality-of-life time, then patients should
not undergo this therapy even if minimally invasive.
Lastly, either within their Limitation paragraph which they have appropriately
revised or their Conclusion paragraph they still do not provide at least an
emphasis that these results are from a high volume center that performs a high
volume of these catheter-based infusional pumps. The authors must mention
potential technical demands as well as the learning curve that is required to
ensure safety and potential efficacy with the use of these hepatic arterial infusion
port catheters. Given that this is no a multi-institutional study there is an inherent
institutional bias because of the technical skill of some of their lead authors that
is not at least highlighted in the Limitations or the Conclusion of the manuscript
that should be at least mentioned so that the prospective reader does not take
this procedure as an overly simplified type of therapy.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
NA