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Lancet. <#> 2008 Jul 12;372(9633):145-54. Epub 2008 Jul 3.


  An adjuvant autologous therapeutic vaccine (HSPPC-96; vitespen) versus
  observation alone for patients at high risk of recurrence after
  nephrectomy for renal cell carcinoma: a multicentre, open-label,
  randomised phase III trial.

Wood C </pubmed?term=%22Wood%20C%22%5BAuthor%5D>, Srivastava P
</pubmed?term=%22Srivastava%20P%22%5BAuthor%5D>, Bukowski R
</pubmed?term=%22Bukowski%20R%22%5BAuthor%5D>, Lacombe L
</pubmed?term=%22Lacombe%20L%22%5BAuthor%5D>, Gorelov AI
</pubmed?term=%22Gorelov%20AI%22%5BAuthor%5D>, Gorelov S
</pubmed?term=%22Gorelov%20S%22%5BAuthor%5D>, Mulders P
</pubmed?term=%22Mulders%20P%22%5BAuthor%5D>, Zielinski H
</pubmed?term=%22Zielinski%20H%22%5BAuthor%5D>, Hoos A
</pubmed?term=%22Hoos%20A%22%5BAuthor%5D>, Teofilovici F
</pubmed?term=%22Teofilovici%20F%22%5BAuthor%5D>, Isakov L
</pubmed?term=%22Isakov%20L%22%5BAuthor%5D>, Flanigan R
</pubmed?term=%22Flanigan%20R%22%5BAuthor%5D>, Figlin R
</pubmed?term=%22Figlin%20R%22%5BAuthor%5D>, Gupta R
</pubmed?term=%22Gupta%20R%22%5BAuthor%5D>, Escudier B
</pubmed?term=%22Escudier%20B%22%5BAuthor%5D>; C-100-12 RCC Study Group
</pubmed?term=%22C-100-12%20RCC%20Study%20Group%22%5BCorporate%20Author%5D>.


      Collaborators (111)<#>

Madersbacher S </pubmed?term=%22Madersbacher%20S%22>, Marberger M
</pubmed?term=%22Marberger%20M%22>, Richard V
</pubmed?term=%22Richard%20V%22>, Billiet I
</pubmed?term=%22Billiet%20I%22>, Andrianne R
</pubmed?term=%22Andrianne%20R%22>, Focan C
</pubmed?term=%22Focan%20C%22>, Vermorken J
</pubmed?term=%22Vermorken%20J%22>, Chin J
</pubmed?term=%22Chin%20J%22>, Tanguay S
</pubmed?term=%22Tanguay%20S%22>, Klotz L
</pubmed?term=%22Klotz%20L%22>, Gleave M
</pubmed?term=%22Gleave%20M%22>, Jewett M
</pubmed?term=%22Jewett%20M%22>, Lacombe L
</pubmed?term=%22Lacombe%20L%22>, Steinhoff G
</pubmed?term=%22Steinhoff%20G%22>, Barr R
</pubmed?term=%22Barr%20R%22>, Escudier B
</pubmed?term=%22Escudier%20B%22>, Linassier C
</pubmed?term=%22Linassier%20C%22>, Delva R
</pubmed?term=%22Delva%20R%22>, Jacqmin D
</pubmed?term=%22Jacqmin%20D%22>, Caty A </pubmed?term=%22Caty%20A%22>,
Négrier S </pubmed?term=%22N%C3%A9grier%20S%22>, Geoffrois L
</pubmed?term=%22Geoffrois%20L%22>, Gravis G
</pubmed?term=%22Gravis%20G%22>, Peschel CI
</pubmed?term=%22Peschel%20CI%22>, Grünwald V
</pubmed?term=%22Gr%C3%BCnwald%20V%22>, Jakse G
</pubmed?term=%22Jakse%20G%22>, Wirth M </pubmed?term=%22Wirth%20M%22>,
Dietel A </pubmed?term=%22Dietel%20A%22>, Lindner A
</pubmed?term=%22Lindner%20A%22>, Nativ O
</pubmed?term=%22Nativ%20O%22>, Gofrit O
</pubmed?term=%22Gofrit%20O%22>, Sidi A </pubmed?term=%22Sidi%20A%22>,
Fosså S </pubmed?term=%22Foss%C3%A5%20S%22>, Narula R
</pubmed?term=%22Narula%20R%22>, Borkowski A
</pubmed?term=%22Borkowski%20A%22>, Krajka K
</pubmed?term=%22Krajka%20K%22>, Bar K </pubmed?term=%22Bar%20K%22>,
Sikorski A </pubmed?term=%22Sikorski%20A%22>, Chlosta P
</pubmed?term=%22Chlosta%20P%22>, Wyczolkowski M
</pubmed?term=%22Wyczolkowski%20M%22>, Borowka A
</pubmed?term=%22Borowka%20A%22>, Darewicz B
</pubmed?term=%22Darewicz%20B%22>, Zielinski H
</pubmed?term=%22Zielinski%20H%22>, Dobrovolskaya NY
</pubmed?term=%22Dobrovolskaya%20NY%22>, Gorelov AI
</pubmed?term=%22Gorelov%20AI%22>, Mikhailov S
</pubmed?term=%22Mikhailov%20S%22>, Karlov P
</pubmed?term=%22Karlov%20P%22>, Al-Shukri S
</pubmed?term=%22Al-Shukri%20S%22>, Moiseyenko V
</pubmed?term=%22Moiseyenko%20V%22>, Gorelov S
</pubmed?term=%22Gorelov%20S%22>, González-Larriba JL
</pubmed?term=%22Gonz%C3%A1lez-Larriba%20JL%22>, Jiménez-Cruz F
</pubmed?term=%22Jim%C3%A9nez-Cruz%20F%22>, Briones JR
</pubmed?term=%22Briones%20JR%22>, Garcia D
</pubmed?term=%22Garcia%20D%22>, Villavicencio H
</pubmed?term=%22Villavicencio%20H%22>, Wullt B
</pubmed?term=%22Wullt%20B%22>, Johansson E
</pubmed?term=%22Johansson%20E%22>, Norlen BJ
</pubmed?term=%22Norlen%20BJ%22>, Lundstam S
</pubmed?term=%22Lundstam%20S%22>, Ljungberg B
</pubmed?term=%22Ljungberg%20B%22>, Sulser T
</pubmed?term=%22Sulser%20T%22>, Mulders PF
</pubmed?term=%22Mulders%20PF%22>, Oliver T
</pubmed?term=%22Oliver%20T%22>, Newman H
</pubmed?term=%22Newman%20H%22>, Hegde U </pubmed?term=%22Hegde%20U%22>,
Reed D </pubmed?term=%22Reed%20D%22>, Amato R
</pubmed?term=%22Amato%20R%22>, Poll W </pubmed?term=%22Poll%20W%22>,
Shalhav AL </pubmed?term=%22Shalhav%20AL%22>, Wood C
</pubmed?term=%22Wood%20C%22>, Soloway M
</pubmed?term=%22Soloway%20M%22>, Crawford D
</pubmed?term=%22Crawford%20D%22>, Ratner M
</pubmed?term=%22Ratner%20M%22>, Sahasrabudhe D
</pubmed?term=%22Sahasrabudhe%20D%22>, Grob BM
</pubmed?term=%22Grob%20BM%22>, Rodriguez R
</pubmed?term=%22Rodriguez%20R%22>, Kabbinavar F
</pubmed?term=%22Kabbinavar%20F%22>, See W </pubmed?term=%22See%20W%22>,
Andriole G </pubmed?term=%22Andriole%20G%22>, Bergreen P
</pubmed?term=%22Bergreen%20P%22>, Flanigan R
</pubmed?term=%22Flanigan%20R%22>, Weiser A
</pubmed?term=%22Weiser%20A%22>, Fishman M
</pubmed?term=%22Fishman%20M%22>, Kuzel T
</pubmed?term=%22Kuzel%20T%22>, Babayan R
</pubmed?term=%22Babayan%20R%22>, Campbell S
</pubmed?term=%22Campbell%20S%22>, Schwartzberg L
</pubmed?term=%22Schwartzberg%20L%22>, O'Donnell M
</pubmed?term=%22O'Donnell%20M%22>, Rowland R
</pubmed?term=%22Rowland%20R%22>, Thompson J
</pubmed?term=%22Thompson%20J%22>, Plante M
</pubmed?term=%22Plante%20M%22>, Ebbinghaus S
</pubmed?term=%22Ebbinghaus%20S%22>, Richart J
</pubmed?term=%22Richart%20J%22>, Rosenberg J
</pubmed?term=%22Rosenberg%20J%22>, Urba W
</pubmed?term=%22Urba%20W%22>, Blute M </pubmed?term=%22Blute%20M%22>,
Tomera K </pubmed?term=%22Tomera%20K%22>, Clark P
</pubmed?term=%22Clark%20P%22>, Reddy S </pubmed?term=%22Reddy%20S%22>,
Klein F </pubmed?term=%22Klein%20F%22>, Smith A
</pubmed?term=%22Smith%20A%22>, Thrasher JB
</pubmed?term=%22Thrasher%20JB%22>, Bilhartz D
</pubmed?term=%22Bilhartz%20D%22>, Gomella L
</pubmed?term=%22Gomella%20L%22>, Vestal JC
</pubmed?term=%22Vestal%20JC%22>, Quinn D
</pubmed?term=%22Quinn%20D%22>, Monnig WB
</pubmed?term=%22Monnig%20WB%22>, Pattaras J
</pubmed?term=%22Pattaras%20J%22>, Teigland CM
</pubmed?term=%22Teigland%20CM%22>, Steckel J
</pubmed?term=%22Steckel%20J%22>, Sosman J </pubmed?term=%22Sosman%20J%22>.


      Source

M D Anderson Cancer Center, Houston, TX, USA. cgwood@mdanderson.org


      Abstract


        BACKGROUND:

Treatment of localised renal cell carcinoma consists of partial or
radical nephrectomy. A substantial proportion of patients are at risk
for recurrence because no effective adjuvant therapy exists. We
investigated the use of an autologous, tumour-derived heat-shock protein
(glycoprotein 96)-peptide complex (HSPPC-96; vitespen) as adjuvant
treatment in patients at high risk of recurrence after resection of
locally advanced renal cell carcinoma.


        METHODS:

In this open-label trial, patients were randomly assigned to receive
either vitespen (n=409) or observation alone (n=409) after nephrectomy.
Randomisation was done in a one to one ratio by a computer-generated
pseudo-random number generator, with a block size of four, and was
stratified by performance score, lymph node status, and nuclear grade.
Vitespen was given intradermally once a week for 4 weeks, then every 2
weeks until vaccine depletion. The primary endpoint was recurrence-free
survival. The final analysis of recurrence-free survival was planned to
take place after 214 or more events of disease recurrence or deaths
before recurrence had occurred. Analysis was by intention to treat
(ITT). This study is registered with ClinicalTrials.gov, number NCT00033904.


        FINDINGS:

48 patients in the vitespen group and 42 in the observation group were
excluded from the ITT population because they did not meet post-surgery
inclusion criteria; the ITT population thus consisted of 361 patients in
the vitespen group and 367 in the observation group. Final analysis of
recurrence-free survival was triggered in November, 2005. Re-review of
all patients in the ITT population by the clinical events committee
identified 149 actual recurrences (73 in the vitespen group and 76 in
the observation group), nine deaths before recurrence (two in the
vitespen group and seven in the observation group), and 124 patients
with baseline metastatic or residual disease (61 in the vitespen group
and 63 in the observation group). Thus, after a median follow-up of 1.9
years (IQR 0.9-2.5) in the ITT population, recurrence events were
reported in 136 (37.7%) patients in the vitespen group and 146 (39.8%)
in the observation group (hazard ratio 0.923, 95% CI 0.729-1.169;
p=0.506). After continued follow-up until March, 2007, there had been 70
deaths in the vitespen group and 72 in the observation group (p=0.896);
however, overall survival data were not mature, and patients continue to
be followed up for survival. In predefined exploratory analyses by AJCC
stage, recurrence events in patients with stage I or II disease were
reported in 19 (15.2%) patients in the vitespen group and 31 (27.0%) in
the observation group (hazard ratio 0.576, 95% CI 0.324-1.023; p=0.056).
The most commonly reported adverse events in the vitespen group were
injection-site erythema (n=158) and injection-site induration (n=153).
One serious adverse event-autoimmune thyroiditis of grade 2 severity-was
reported in the vitespen group; no treatment-related grade 3 or 4
adverse events were reported.


        INTERPRETATION:

No difference in recurrence-free survival was seen between patients
given vitespen and those who received no treatment after nephrectomy for
renal cell carcinoma. A possible improvement in recurrence-free survival
in patients with early stage disease who received vitespen will require
further validation.


      Comment in

  * Lancet. 2008 Jul 12;372(9633):92-3. </pubmed/18602687.1>
  * Nat Clin Pract Urol. 2008 Dec;5(12):644-5. </pubmed/19002125.1>

PMID:
    18602688
    [PubMed - indexed for MEDLINE] 


      Publication Types, MeSH Terms, Substances, Secondary Source ID<#>


        Publication Types

  * Clinical Trial, Phase III <#>
  * Multicenter Study <#>
  * Randomized Controlled Trial <#>
  * Research Support, Non-U.S. Gov't <#>


        MeSH Terms

  * Adult <#>
  * Aged <#>
  * Aged, 80 and over <#>
  * Cancer Vaccines/adverse effects <#>
  * Cancer Vaccines/therapeutic use* <#>
  * Disease-Free Survival <#>
  * Female <#>
  * Heat-Shock Proteins/adverse effects <#>
  * Heat-Shock Proteins/therapeutic use* <#>
  * Humans <#>
  * Kidney Neoplasms/pathology <#>
  * Kidney Neoplasms/prevention & control* <#>
  * Kidney Neoplasms/surgery <#>
  * Male <#>
  * Middle Aged <#>
  * Neoplasm Recurrence, Local/prevention & control* <#>
  * Observation <#>
  * Postoperative Period <#>
  * Risk Factors <#>


        Substances

  * Cancer Vaccines <#>
  * Heat-Shock Proteins <#>
  * vitespin <#>


        Secondary Source ID

  * ClinicalTrials.gov/NCT00033904 <#>


      LinkOut - more resources<#>


        Full Text Sources

  * Elsevier Science
    <http://linkinghub.elsevier.com/retrieve/pii/S0140-6736(08)60697-2>
  * EBSCO
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<#>

  * Adjuvant autologous renal tumour cell vaccine and risk of tumour
    progression in patients with renal-cell carcinoma after radical
    nephrectomy: phase III, randomised controlled trial.
    </pubmed/14987883> [Lancet. 2004]
    Adjuvant autologous renal tumour cell vaccine and risk of tumour
    progression in patients with renal-cell carcinoma after radical
    nephrectomy: phase III, randomised controlled trial.
    /Jocham D, Richter A, Hoffmann L, Iwig K, Fahlenkamp D, Zakrzewski
    G, Schmitt E, Dannenberg T, Lehmacher W, von Wietersheim J, et al.
    //Lancet. 2004 Feb 21; 363(9409):594-9. /
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    /Eggermont AM, Suciu S, Santinami M, Testori A, Kruit WH, Marsden J,
    Punt CJ, Salès F, Gore M, Mackie R, et al. //Lancet. 2008 Jul 12;
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  * Efficacy of everolimus in advanced renal cell carcinoma: a
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    /Motzer RJ, Escudier B, Oudard S, Hutson TE, Porta C, Bracarda S,
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  * Review Vaccine therapy in patients with renal cell carcinoma.
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    Review Vaccine therapy in patients with renal cell carcinoma.
    /Van Poppel H, Joniau S, Van Gool SW. //Eur Urol. 2009 Jun;
    55(6):1333-42. Epub 2009 Jan 30./
  * Review Oblimersen: Augmerosen, BCL-2 antisense oligonucleotide -
    Genta, G 3139, GC 3139, oblimersen sodium. </pubmed/17767397> [Drugs
    R D. 2007]
    Review Oblimersen: Augmerosen, BCL-2 antisense oligonucleotide -
    Genta, G 3139, GC 3139, oblimersen sodium.
    /. //Drugs R D. 2007; 8(5):321-34. /

See reviews...
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      Cited by 12 PubMed Central articles

<#>

  * Heat shock protein 70/peptide complexes: potent mediators for the
    generation of antiviral T cells particularly with regard to low
    precursor frequencies. </pubmed/21992180> [J Transl Med. 2011]
    Heat shock protein 70/peptide complexes: potent mediators for the
    generation of antiviral T cells particularly with regard to low
    precursor frequencies.
    /Tischer S, Basila M, Maecker-Kolhoff B, Immenschuh S, Oelke M,
    Blasczyk R, Eiz-Vesper B. //J Transl Med. 2011 Oct 12; 9:175. Epub
    2011 Oct 12./
  * Antitumor activity of mixed heat shock protein/peptide vaccine and
    cyclophosphamide plus interleukin-12 in mice sarcoma.
    </pubmed/21352555> [J Exp Clin Cancer Res. 2011]
    Antitumor activity of mixed heat shock protein/peptide vaccine and
    cyclophosphamide plus interleukin-12 in mice sarcoma.
    /Guo QY, Yuan M, Peng J, Cui XM, Song G, Sui X, Lu SB. //J Exp Clin
    Cancer Res. 2011 Feb 26; 30:24. Epub 2011 Feb 26./
  * Hsp110-mediated enhancement of CD4+ T cell responses to the envelope
    glycoprotein of members of the family Flaviviridae in vitro does not
    occur in vivo. </pubmed/21147937> [Clin Vaccine Immunol. 2011]
    Hsp110-mediated enhancement of CD4+ T cell responses to the envelope
    glycoprotein of members of the family Flaviviridae in vitro does not
    occur in vivo.
    /McLaughlin K, Carr VB, Iqbal M, Seago J, Lefevre EA, Robinson L,
    Prentice H, Charleston B. //Clin Vaccine Immunol. 2011 Feb;
    18(2):311-7. Epub 2010 Dec 8./

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