Difference between revisions of "B-cell acute lymphoblastic leukemia, pediatric, Ph-positive"

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m (Text replacement - "====CNS prophylaxis" to "====CNS therapy, prophylaxis")
m
Line 14: Line 14:
 
==[https://www.nccn.org/ NCCN]==
 
==[https://www.nccn.org/ NCCN]==
 
*[https://www.nccn.org/professionals/physician_gls/pdf/ped_all.pdf NCCN Guidelines - Pediatric Acute Lymphoblastic Leukemia]
 
*[https://www.nccn.org/professionals/physician_gls/pdf/ped_all.pdf NCCN Guidelines - Pediatric Acute Lymphoblastic Leukemia]
−
 
 
=Upfront induction therapy=
 
=Upfront induction therapy=
 
==Daunorubicin, Pegaspargase, Vincristine, Prednisone, Dasatinib {{#subobject:d3ob07|Regimen=1}}==
 
==Daunorubicin, Pegaspargase, Vincristine, Prednisone, Dasatinib {{#subobject:d3ob07|Regimen=1}}==
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:f30uhf|Variant=1}}===
 
===Regimen {{#subobject:f30uhf|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
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!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6990720/ Shen et al. 2020 (CCCG-ALL-2015)]
+
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6990720/ Shen et al. 2020 (CCCG-ALL-2015-Ph)]
 
|2015-2018
 
|2015-2018
 
| style="background-color:#1a9851" |Phase 3 (E-switch-ic)
 
| style="background-color:#1a9851" |Phase 3 (E-switch-ic)
Line 33: Line 32:
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 
*[[Daunorubicin (Cerubidine)]]
 
*[[Daunorubicin (Cerubidine)]]
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====Targeted therapy====
 
====Targeted therapy====
 
*[[Dasatinib (Sprycel)]] 80 mg/m<sup>2</sup>/day PO
 
*[[Dasatinib (Sprycel)]] 80 mg/m<sup>2</sup>/day PO
−
 
 
'''28-day course'''
 
'''28-day course'''
 +
</div>
 +
<div class="toccolours" style="background-color:#cbd5e7">
 
====Subsequent treatment====
 
====Subsequent treatment====
 
*See paper for details
 
*See paper for details
−
 
+
</div></div>
 
===References===
 
===References===
−
# '''CCCG-ALL-2015:''' Shen S, Chen X, Cai J, Yu J, Gao J, Hu S, Zhai X, Liang C, Ju X, Jiang H, Jin R, Wu X, Wang N, Tian X, Pan K, Jiang H, Sun L, Fang Y, Li CK, Hu Q, Yang M, Zhu Y, Zhang H, Li C, Pei D, Jeha S, Yang JJ, Cheng C, Tang J, Zhu X, Pui CH. Effect of Dasatinib vs Imatinib in the Treatment of Pediatric Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Randomized Clinical Trial. JAMA Oncol. 2020 Mar 1;6(3):358-366. Epub 2020 Jan 16. [https://doi.org/10.1001/jamaoncol.2019.5868 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6990720/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/31944221 PubMed] ChiCTR-IPR-14005706
+
# '''CCCG-ALL-2015-Ph:''' Shen S, Chen X, Cai J, Yu J, Gao J, Hu S, Zhai X, Liang C, Ju X, Jiang H, Jin R, Wu X, Wang N, Tian X, Pan K, Jiang H, Sun L, Fang Y, Li CK, Hu Q, Yang M, Zhu Y, Zhang H, Li C, Pei D, Jeha S, Yang JJ, Cheng C, Tang J, Zhu X, Pui CH. Effect of Dasatinib vs Imatinib in the Treatment of Pediatric Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Randomized Clinical Trial. JAMA Oncol. 2020 Mar 1;6(3):358-366. Epub 2020 Jan 16. [https://doi.org/10.1001/jamaoncol.2019.5868 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6990720/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/31944221 PubMed] ChiCTR-IPR-14005706
 
# '''COG AALL1122:''' NCT01460160
 
# '''COG AALL1122:''' NCT01460160
−
 
 
==Daunorubicin, Pegaspargase, Vincristine, Prednisone, Imatinib {{#subobject:d3yhc7|Regimen=1}}==
 
==Daunorubicin, Pegaspargase, Vincristine, Prednisone, Imatinib {{#subobject:d3yhc7|Regimen=1}}==
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:f3e30f|Variant=1}}===
 
===Regimen {{#subobject:f3e30f|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
Line 60: Line 60:
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6990720/ Shen et al. 2020 (CCCG-ALL-2015)]
+
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6990720/ Shen et al. 2020 (CCCG-ALL-2015-Ph)]
 
|2015-2018
 
|2015-2018
 
| style="background-color:#1a9851" |Phase 3 (E-switch-ic)
 
| style="background-color:#1a9851" |Phase 3 (E-switch-ic)
Line 67: Line 67:
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 
*[[Daunorubicin (Cerubidine)]]
 
*[[Daunorubicin (Cerubidine)]]
Line 75: Line 76:
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Imatinib (Gleevec)]] 300 mg/m<sup>2</sup>/day PO
 
*[[Imatinib (Gleevec)]] 300 mg/m<sup>2</sup>/day PO
−
 
 
'''28-day course'''
 
'''28-day course'''
 +
</div>
 +
<div class="toccolours" style="background-color:#cbd5e7">
 
====Subsequent treatment====
 
====Subsequent treatment====
 
*See paper for details
 
*See paper for details
−
 
+
</div></div>
 
===References===
 
===References===
−
# '''CCCG-ALL-2015:''' Shen S, Chen X, Cai J, Yu J, Gao J, Hu S, Zhai X, Liang C, Ju X, Jiang H, Jin R, Wu X, Wang N, Tian X, Pan K, Jiang H, Sun L, Fang Y, Li CK, Hu Q, Yang M, Zhu Y, Zhang H, Li C, Pei D, Jeha S, Yang JJ, Cheng C, Tang J, Zhu X, Pui CH. Effect of Dasatinib vs Imatinib in the Treatment of Pediatric Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Randomized Clinical Trial. JAMA Oncol. 2020 Mar 1;6(3):358-366. Epub 2020 Jan 16. [https://doi.org/10.1001/jamaoncol.2019.5868 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6990720/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/31944221 PubMed] ChiCTR-IPR-14005706
+
# '''CCCG-ALL-2015-Ph:''' Shen S, Chen X, Cai J, Yu J, Gao J, Hu S, Zhai X, Liang C, Ju X, Jiang H, Jin R, Wu X, Wang N, Tian X, Pan K, Jiang H, Sun L, Fang Y, Li CK, Hu Q, Yang M, Zhu Y, Zhang H, Li C, Pei D, Jeha S, Yang JJ, Cheng C, Tang J, Zhu X, Pui CH. Effect of Dasatinib vs Imatinib in the Treatment of Pediatric Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Randomized Clinical Trial. JAMA Oncol. 2020 Mar 1;6(3):358-366. Epub 2020 Jan 16. [https://doi.org/10.1001/jamaoncol.2019.5868 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6990720/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/31944221 PubMed] ChiCTR-IPR-14005706
−
 
 
 
=Consolidation after upfront therapy (including post-remission therapy)=
 
=Consolidation after upfront therapy (including post-remission therapy)=
 
''Note that many of these regimens are complex and as such will be referred to by their study name, not by the individual drug names. This is also a phase of treatment often referred to as post-remission or postinduction therapy.''
 
''Note that many of these regimens are complex and as such will be referred to by their study name, not by the individual drug names. This is also a phase of treatment often referred to as post-remission or postinduction therapy.''
−
 
 
==Etoposide, Ifosfamide, Imatinib {{#subobject:1a7aa5|Regimen=1}}==
 
==Etoposide, Ifosfamide, Imatinib {{#subobject:1a7aa5|Regimen=1}}==
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:8jvu16|Variant=1}}===
 
===Regimen {{#subobject:8jvu16|Variant=1}}===
 
{| class="wikitable" style="width: 60%; text-align:center;"  
 
{| class="wikitable" style="width: 60%; text-align:center;"  
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|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 
*[[Etoposide (Vepesid)]]
 
*[[Etoposide (Vepesid)]]
Line 104: Line 105:
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Imatinib (Gleevec)]] 340 mg/m<sup>2</sup> PO once per day
 
*[[Imatinib (Gleevec)]] 340 mg/m<sup>2</sup> PO once per day
−
 
+
</div></div>
 
===References===
 
===References===
 
# '''COG AALL0031:''' Schultz KR, Bowman WP, Aledo A, Slayton WB, Sather H, Devidas M, Wang C, Davies SM, Gaynon PS, Trigg M, Rutledge R, Burden L, Jorstad D, Carroll A, Heerema NA, Winick N, Borowitz MJ, Hunger SP, Carroll WL, Camitta B. Improved early event-free survival with imatinib in Philadelphia chromosome-positive acute lymphoblastic leukemia: a Children's Oncology Group study. J Clin Oncol. 2009 Nov 1;27(31):5175-81. Epub 2009 Oct 5. [https://doi.org/10.1200/JCO.2008.21.2514 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2773475/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/19805687 PubMed] NCT00022737
 
# '''COG AALL0031:''' Schultz KR, Bowman WP, Aledo A, Slayton WB, Sather H, Devidas M, Wang C, Davies SM, Gaynon PS, Trigg M, Rutledge R, Burden L, Jorstad D, Carroll A, Heerema NA, Winick N, Borowitz MJ, Hunger SP, Carroll WL, Camitta B. Improved early event-free survival with imatinib in Philadelphia chromosome-positive acute lymphoblastic leukemia: a Children's Oncology Group study. J Clin Oncol. 2009 Nov 1;27(31):5175-81. Epub 2009 Oct 5. [https://doi.org/10.1200/JCO.2008.21.2514 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2773475/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/19805687 PubMed] NCT00022737
 
## '''Update:''' Schultz KR, Carroll A, Heerema NA, Bowman WP, Aledo A, Slayton WB, Sather H, Devidas M, Zheng HW, Davies SM, Gaynon PS, Trigg M, Rutledge R, Jorstad D, Winick N, Borowitz MJ, Hunger SP, Carroll WL, Camitta B; Children’s Oncology Group. Long-term follow-up of imatinib in pediatric Philadelphia chromosome-positive acute lymphoblastic leukemia: Children's Oncology Group study AALL0031. Leukemia. 2014 Jul;28(7):1467-71. Epub 2014 Jan 20. [https://www.nature.com/articles/leu201430 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4282929/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/24441288 PubMed]
 
## '''Update:''' Schultz KR, Carroll A, Heerema NA, Bowman WP, Aledo A, Slayton WB, Sather H, Devidas M, Zheng HW, Davies SM, Gaynon PS, Trigg M, Rutledge R, Jorstad D, Winick N, Borowitz MJ, Hunger SP, Carroll WL, Camitta B; Children’s Oncology Group. Long-term follow-up of imatinib in pediatric Philadelphia chromosome-positive acute lymphoblastic leukemia: Children's Oncology Group study AALL0031. Leukemia. 2014 Jul;28(7):1467-71. Epub 2014 Jan 20. [https://www.nature.com/articles/leu201430 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4282929/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/24441288 PubMed]
−
 
 
==Imatinib-based consolidation {{#subobject:1a7885|Regimen=1}}==
 
==Imatinib-based consolidation {{#subobject:1a7885|Regimen=1}}==
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:81b016|Variant=1}}===
 
===Regimen {{#subobject:81b016|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"
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''<sup>1</sup>This regimen did not meet the primary efficacy endpoint in the ITT population, but there was a possible signal in the as-treated population.''<br>
 
''<sup>1</sup>This regimen did not meet the primary efficacy endpoint in the ITT population, but there was a possible signal in the as-treated population.''<br>
 
''See paper for details beyond "IB". To be completed (?)''
 
''See paper for details beyond "IB". To be completed (?)''
 +
<div class="toccolours" style="background-color:#cbd5e8">
 
====Preceding treatment====
 
====Preceding treatment====
 
* Berlin–Frankfurt–Munster high-risk backbone
 
* Berlin–Frankfurt–Munster high-risk backbone
 +
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 
*[[Cyclophosphamide (Cytoxan)]]
 
*[[Cyclophosphamide (Cytoxan)]]
Line 136: Line 139:
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Imatinib (Gleevec)]]
 
*[[Imatinib (Gleevec)]]
−
 
 
====CNS therapy, prophylaxis====
 
====CNS therapy, prophylaxis====
 
*[[Methotrexate (MTX)]]
 
*[[Methotrexate (MTX)]]
−
 
+
</div></div>
 
===References===
 
===References===
 
# '''EsPhALL:''' Biondi A, Schrappe M, De Lorenzo P, Castor A, Lucchini G, Gandemer V, Pieters R, Stary J, Escherich G, Campbell M, Li CK, Vora A, Aricò M, Röttgers S, Saha V, Valsecchi MG. Imatinib after induction for treatment of children and adolescents with Philadelphia-chromosome-positive acute lymphoblastic leukaemia (EsPhALL): a randomised, open-label, intergroup study. Lancet Oncol. 2012 Sep;13(9):936-45. Epub 2012 Aug 14. [https://doi.org/10.1016/S1470-2045(12)70377-7 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3431502/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/22898679 PubMed] NCT00287105
 
# '''EsPhALL:''' Biondi A, Schrappe M, De Lorenzo P, Castor A, Lucchini G, Gandemer V, Pieters R, Stary J, Escherich G, Campbell M, Li CK, Vora A, Aricò M, Röttgers S, Saha V, Valsecchi MG. Imatinib after induction for treatment of children and adolescents with Philadelphia-chromosome-positive acute lymphoblastic leukaemia (EsPhALL): a randomised, open-label, intergroup study. Lancet Oncol. 2012 Sep;13(9):936-45. Epub 2012 Aug 14. [https://doi.org/10.1016/S1470-2045(12)70377-7 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3431502/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/22898679 PubMed] NCT00287105
−
 
 
[[Category:B-cell acute lymphoblastic leukemia regimens]]
 
[[Category:B-cell acute lymphoblastic leukemia regimens]]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Acute lymphoblastic leukemias]]
 
[[Category:Acute lymphoblastic leukemias]]
 
[[Category:Pediatric hematologic neoplasms]]
 
[[Category:Pediatric hematologic neoplasms]]

Revision as of 13:29, 21 January 2023

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Section editor transclusions This page contains studies that were specific to pediatric populations. For the more general pediatric B-ALL page, follow this link. For the more general Ph+ B-ALL page, follow this link.

5 regimens on this page
5 variants on this page


Guidelines

NCCN

Upfront induction therapy

Daunorubicin, Pegaspargase, Vincristine, Prednisone, Dasatinib

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Shen et al. 2020 (CCCG-ALL-2015-Ph) 2015-2018 Phase 3 (E-switch-ic) Daunorubicin, Pegaspargase, Vincristine, Prednisone, Imatinib Superior EFS48

Chemotherapy

Glucocorticoid therapy

Targeted therapy

28-day course

Subsequent treatment

  • See paper for details

References

  1. CCCG-ALL-2015-Ph: Shen S, Chen X, Cai J, Yu J, Gao J, Hu S, Zhai X, Liang C, Ju X, Jiang H, Jin R, Wu X, Wang N, Tian X, Pan K, Jiang H, Sun L, Fang Y, Li CK, Hu Q, Yang M, Zhu Y, Zhang H, Li C, Pei D, Jeha S, Yang JJ, Cheng C, Tang J, Zhu X, Pui CH. Effect of Dasatinib vs Imatinib in the Treatment of Pediatric Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Randomized Clinical Trial. JAMA Oncol. 2020 Mar 1;6(3):358-366. Epub 2020 Jan 16. link to original article link to PMC article PubMed ChiCTR-IPR-14005706
  2. COG AALL1122: NCT01460160

Daunorubicin, Pegaspargase, Vincristine, Prednisone, Imatinib

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Shen et al. 2020 (CCCG-ALL-2015-Ph) 2015-2018 Phase 3 (E-switch-ic) Daunorubicin, Pegaspargase, Vincristine, Prednisone, Dasatinib Inferior EFS48

Chemotherapy

Glucocorticoid therapy

Targeted therapy

28-day course

Subsequent treatment

  • See paper for details

References

  1. CCCG-ALL-2015-Ph: Shen S, Chen X, Cai J, Yu J, Gao J, Hu S, Zhai X, Liang C, Ju X, Jiang H, Jin R, Wu X, Wang N, Tian X, Pan K, Jiang H, Sun L, Fang Y, Li CK, Hu Q, Yang M, Zhu Y, Zhang H, Li C, Pei D, Jeha S, Yang JJ, Cheng C, Tang J, Zhu X, Pui CH. Effect of Dasatinib vs Imatinib in the Treatment of Pediatric Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Randomized Clinical Trial. JAMA Oncol. 2020 Mar 1;6(3):358-366. Epub 2020 Jan 16. link to original article link to PMC article PubMed ChiCTR-IPR-14005706

Consolidation after upfront therapy (including post-remission therapy)

Note that many of these regimens are complex and as such will be referred to by their study name, not by the individual drug names. This is also a phase of treatment often referred to as post-remission or postinduction therapy.

Etoposide, Ifosfamide, Imatinib

Regimen

Study Years of enrollment Evidence
Schultz et al. 2009 (COG AALL0031) 2002-2006 Phase 2 (RT)

Chemotherapy

Targeted therapy

References

  1. COG AALL0031: Schultz KR, Bowman WP, Aledo A, Slayton WB, Sather H, Devidas M, Wang C, Davies SM, Gaynon PS, Trigg M, Rutledge R, Burden L, Jorstad D, Carroll A, Heerema NA, Winick N, Borowitz MJ, Hunger SP, Carroll WL, Camitta B. Improved early event-free survival with imatinib in Philadelphia chromosome-positive acute lymphoblastic leukemia: a Children's Oncology Group study. J Clin Oncol. 2009 Nov 1;27(31):5175-81. Epub 2009 Oct 5. link to original article link to PMC article PubMed NCT00022737
    1. Update: Schultz KR, Carroll A, Heerema NA, Bowman WP, Aledo A, Slayton WB, Sather H, Devidas M, Zheng HW, Davies SM, Gaynon PS, Trigg M, Rutledge R, Jorstad D, Winick N, Borowitz MJ, Hunger SP, Carroll WL, Camitta B; Children’s Oncology Group. Long-term follow-up of imatinib in pediatric Philadelphia chromosome-positive acute lymphoblastic leukemia: Children's Oncology Group study AALL0031. Leukemia. 2014 Jul;28(7):1467-71. Epub 2014 Jan 20. link to original article link to PMC article PubMed

Imatinib-based consolidation

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Biondi et al. 2012 (EsPhALL) 2004-2009 Phase 3 (E-esc) No imatinib in consolidation Did not meet primary endpoint of DFS481

1This regimen did not meet the primary efficacy endpoint in the ITT population, but there was a possible signal in the as-treated population.
See paper for details beyond "IB". To be completed (?)

Preceding treatment

  • Berlin–Frankfurt–Munster high-risk backbone

Chemotherapy

Targeted therapy

CNS therapy, prophylaxis

References

  1. EsPhALL: Biondi A, Schrappe M, De Lorenzo P, Castor A, Lucchini G, Gandemer V, Pieters R, Stary J, Escherich G, Campbell M, Li CK, Vora A, Aricò M, Röttgers S, Saha V, Valsecchi MG. Imatinib after induction for treatment of children and adolescents with Philadelphia-chromosome-positive acute lymphoblastic leukaemia (EsPhALL): a randomised, open-label, intergroup study. Lancet Oncol. 2012 Sep;13(9):936-45. Epub 2012 Aug 14. link to original article link to PMC article PubMed NCT00287105
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