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: 1Date:5 February 2013
Reviewer: Giammaria Fiorentini
Reviewer's report:
Interventionally implanted port catheter systems for hepatic arterial infusion of
chemotherapy in patients with primary liver cancer: A phase II-study.
Marianne Sinn, Annett Nicolaou, Jens Ricke, Pjotr Podrabsky, Daniel Seehofer,
Bernhard Gebauer, Maciej Pech, Bernd Dorken, Hanno Riess and Bert
Hildebrandt BMC Gastroenterology Research article
Is the question posed by the authors well defined? YES,
concerning IIPCS implantation
2. Are the methods appropriate and well described? YES,
concerning IIPCS implantation. It is unclear the schedule of therapy, probably
used in liver metastases from colorectal cancer but unknown for primary liver
cancer. In biliary tract tumours the most used drugs are oxaliplatin and
gemcitabine (GEMOX), Fluorouracil is rarely considered.
3. Are the data sound? YES for the implantation of the device, but not sound for
chemotherapy 4. Does the manuscript adhere to the relevant standards for
reporting and data deposition? Substantially YES 5. Are the discussion and
conclusions well balanced and adequately supported by the data? No because in
the field of HCC, HAI is rarely considered and substantially non accepted. No
randomized trials exist.
6. Are limitations of the work clearly stated? YES, the Authors stated their
limitations and confirm doubts about the real utility of this approach (HAI in HCC)
even if implantation of the device is well done.
7. Do the authors clearly acknowledge any work upon which they are building,
both published and unpublished? No, forgotten Arai's data 8. Do the title and
abstract accurately convey what has been found? No because the phase II study
is devoted to observe response rate and efficacy of any treatment. Here the
chemotherapy is not effective and quite toxic ( hemorrhage, bone marrow
toxicity) and substantially there is any indication to move from TACE to IIPCS
9. Is the writing acceptable NO, A MAJOR REVISION IS REQUIRED
THERE ARE SOME POINT TO DISCUSS:
1) HAI is not routinely applied in HCC, the vast majority of experiences are in
colorectal liver mets.
2) HAI is rarely used in ICC, even if in this tumors - orfan drug- does not exist any
active strategy
3) the chemotherapy schedule is unknown. Data on oxaliplatin activity in HCC
are pour. The toxic effects reported are significant, and substantially more
important that we observe after TACE, gastrointestinal hemorrhage is related to
tip position ( wrong perfusion) and to drug damage. Did the patients receive IPP?
Others questions for Authors:
The tip of catheters are fixed or floating free?
The port infection is the first cause of complications. Did authors try to save it
using antibiotics. Did they explant the port?
How is rotary motion of the limb where is placed the IIPCS Do the authors
implant the Port always in the groin? Do thy consider that this is a place easier to
be infected?
How many patients have chirrosis?
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: 1Date:5 February 2013
Reviewer: Giammaria Fiorentini
Reviewer's report:
Interventionally implanted port catheter systems for hepatic arterial infusion of
chemotherapy in patients with primary liver cancer: A phase II-study.
Marianne Sinn, Annett Nicolaou, Jens Ricke, Pjotr Podrabsky, Daniel Seehofer,
Bernhard Gebauer, Maciej Pech, Bernd Dorken, Hanno Riess and Bert
Hildebrandt BMC Gastroenterology Research article
Is the question posed by the authors well defined? YES,
concerning IIPCS implantation
2. Are the methods appropriate and well described? YES,
concerning IIPCS implantation. It is unclear the schedule of therapy, probably
used in liver metastases from colorectal cancer but unknown for primary liver
cancer. In biliary tract tumours the most used drugs are oxaliplatin and
gemcitabine (GEMOX), Fluorouracil is rarely considered.
3. Are the data sound? YES for the implantation of the device, but not sound for
chemotherapy 4. Does the manuscript adhere to the relevant standards for
reporting and data deposition? Substantially YES 5. Are the discussion and
conclusions well balanced and adequately supported by the data? No because in
the field of HCC, HAI is rarely considered and substantially non accepted. No
randomized trials exist.
6. Are limitations of the work clearly stated? YES, the Authors stated their
limitations and confirm doubts about the real utility of this approach (HAI in HCC)
even if implantation of the device is well done.
7. Do the authors clearly acknowledge any work upon which they are building,
both published and unpublished? No, forgotten Arai's data 8. Do the title and
abstract accurately convey what has been found? No because the phase II study
is devoted to observe response rate and efficacy of any treatment. Here the
chemotherapy is not effective and quite toxic ( hemorrhage, bone marrow
toxicity) and substantially there is any indication to move from TACE to IIPCS
9. Is the writing acceptable NO, A MAJOR REVISION IS REQUIRED
THERE ARE SOME POINT TO DISCUSS:
1) HAI is not routinely applied in HCC, the vast majority of experiences are in
colorectal liver mets.
2) HAI is rarely used in ICC, even if in this tumors - orfan drug- does not exist any
active strategy
3) the chemotherapy schedule is unknown. Data on oxaliplatin activity in HCC
are pour. The toxic effects reported are significant, and substantially more
important that we observe after TACE, gastrointestinal hemorrhage is related to
tip position ( wrong perfusion) and to drug damage. Did the patients receive IPP?
Others questions for Authors:
The tip of catheters are fixed or floating free?
The port infection is the first cause of complications. Did authors try to save it
using antibiotics. Did they explant the port?
How is rotary motion of the limb where is placed the IIPCS Do the authors
implant the Port always in the groin? Do thy consider that this is a place easier to
be infected?
How many patients have chirrosis?
Please review this paper.
user
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: 1Date:5 February 2013
Reviewer: Giammaria Fiorentini
Reviewer's report:
Interventionally implanted port catheter systems for hepatic arterial infusion of
chemotherapy in patients with primary liver cancer: A phase II-study.
Marianne Sinn, Annett Nicolaou, Jens Ricke, Pjotr Podrabsky, Daniel Seehofer,
Bernhard Gebauer, Maciej Pech, Bernd Dorken, Hanno Riess and Bert
Hildebrandt BMC Gastroenterology Research article
Is the question posed by the authors well defined? YES,
concerning IIPCS implantation
2. Are the methods appropriate and well described? YES,
concerning IIPCS implantation. It is unclear the schedule of therapy, probably
used in liver metastases from colorectal cancer but unknown for primary liver
cancer. In biliary tract tumours the most used drugs are oxaliplatin and
gemcitabine (GEMOX), Fluorouracil is rarely considered.
3. Are the data sound? YES for the implantation of the device, but not sound for
chemotherapy 4. Does the manuscript adhere to the relevant standards for
reporting and data deposition? Substantially YES 5. Are the discussion and
conclusions well balanced and adequately supported by the data? No because in
the field of HCC, HAI is rarely considered and substantially non accepted. No
randomized trials exist.
6. Are limitations of the work clearly stated? YES, the Authors stated their
limitations and confirm doubts about the real utility of this approach (HAI in HCC)
even if implantation of the device is well done.
7. Do the authors clearly acknowledge any work upon which they are building,
both published and unpublished? No, forgotten Arai's data 8. Do the title and
abstract accurately convey what has been found? No because the phase II study
is devoted to observe response rate and efficacy of any treatment. Here the
chemotherapy is not effective and quite toxic ( hemorrhage, bone marrow
toxicity) and substantially there is any indication to move from TACE to IIPCS
9. Is the writing acceptable NO, A MAJOR REVISION IS REQUIRED
THERE ARE SOME POINT TO DISCUSS:
1) HAI is not routinely applied in HCC, the vast majority of experiences are in
colorectal liver mets.
2) HAI is rarely used in ICC, even if in this tumors - orfan drug- does not exist any
active strategy
3) the chemotherapy schedule is unknown. Data on oxaliplatin activity in HCC
are pour. The toxic effects reported are significant, and substantially more
important that we observe after TACE, gastrointestinal hemorrhage is related to
tip position ( wrong perfusion) and to drug damage. Did the patients receive IPP?
Others questions for Authors:
The tip of catheters are fixed or floating free?
The port infection is the first cause of complications. Did authors try to save it
using antibiotics. Did they explant the port?
How is rotary motion of the limb where is placed the IIPCS Do the authors
implant the Port always in the groin? Do thy consider that this is a place easier to
be infected?
How many patients have chirrosis?
assistant