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JNCI Journal of the National Cancer Institute 2000 92(3):205-216; doi:10.1093/jnci/92.3.205
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Journal of the National Cancer Institute, Vol. 92, No. 3, 205-216, February 2, 2000
© 2000 Oxford University Press

SPECIAL ARTICLE

New Guidelines to Evaluate the Response to Treatment in Solid Tumors

Patrick Therasse, Susan G. Arbuck, Elizabeth A. Eisenhauer, Jantien Wanders, Richard S. Kaplan, Larry Rubinstein, Jaap Verweij, Martine Van Glabbeke, Allan T. van Oosterom, Michaele C. Christian, Steve G. Gwyther

Affiliations of authors: P. Therasse, J. Verweij, M. Van Glabbeke, A. T. van Oosterom, European Organization for Research and Treatment of Cancer, Brussels, Belgium; S. G. Arbuck, R. S. Kaplan, L. Rubinstein, M. C. Christian, National Cancer Institute, Bethesda, MD; E. A. Eisenhauer, National Cancer Institute of Canada Clinical Trials Group, Kingston, ON, Canada; J. Wanders, New Drug Development Office Oncology, Amsterdam, The Netherlands; S. G. Gwyther, East Surrey Healthcare National Health Service Trust, Redhill, U.K.

Correspondence to: Patrick Therasse, M.D., European Organization for Research and Treatment of Cancer Data Center, Avenue Mounier 83/11, 1200 Brussels, Belgium (e-mail: pth{at}eortc.be).

Anticancer cytotoxic agents go through a process by which their antitumor activity—on the basis of the amount of tumor shrinkage they could generate—has been investigated. In the late 1970s, the International Union Against Cancer and the World Health Organization introduced specific criteria for the codification of tumor response evaluation. In 1994, several organizations involved in clinical research combined forces to tackle the review of these criteria on the basis of the experience and knowledge acquired since then. After several years of intensive discussions, a new set of guidelines is ready that will supersede the former criteria. In parallel to this initiative, one of the participating groups developed a model by which response rates could be derived from unidimensional measurement of tumor lesions instead of the usual bidimensional approach. This new concept has been largely validated by the Response Evaluation Criteria in Solid Tumors Group and integrated into the present guidelines. This special article also provides some philosophic background to clarify the various purposes of response evaluation. It proposes a model by which a combined assessment of all existing lesions, characterized by target lesions (to be measured) and nontarget lesions, is used to extrapolate an overall response to treatment. Methods of assessing tumor lesions are better codified, briefly within the guidelines and in more detail in Appendix I. All other aspects of response evaluation have been discussed, reviewed, and amended whenever appropriate.


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Correspondence about this Article

Re: New Guidelines to Evaluate the Response to Treatment in Solid Tumors [Ovarian Cancer]
Ignace Vergote, Gordon J. S. Rustin, Elisabeth A. Eisenhauer, Gunnar B. Kristensen, Eric Pujade-Lauraine, Mahesh K. B. Parmar, Michael Friedlander, Anders Jakobsen, and Jan B. Vermorken
J Natl Cancer Inst 2000 92: 1534-1535. [Extract] [Full Text] [PDF]

Re: New Guidelines to Evaluate the Response to Treatment in Solid Tumors (Ovarian Cancer)
Gordon J. S. Rustin, Michael Quinn, Tate Thigpen, Andreas du Bois, Eric Pujade-Lauraine, Anders Jakobsen, Elizabeth Eisenhauer, Satoru Sagae, Kathryn Greven, Ignace Vergote, Andres Cervantes, and Jan Vermorken
J Natl Cancer Inst 2004 96: 487-488. [Extract] [Full Text] [PDF]



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 J. Clin. Endocrinol. Metab.Home page
S. I. Sherman
Advances in Chemotherapy of Differentiated Epithelial and Medullary Thyroid Cancers
J. Clin. Endocrinol. Metab., May 1, 2009; 94(5): 1493 - 1499.
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 JCOHome page
G. Goss, D. Ferry, R. Wierzbicki, S. A. Laurie, J. Thompson, B. Biesma, F. R. Hirsch, M. Varella-Garcia, E. Duffield, O. U. Ataman, et al.
Randomized Phase II Study of Gefitinib Compared With Placebo in Chemotherapy-Naive Patients With Advanced Non-Small-Cell Lung Cancer and Poor Performance Status
J. Clin. Oncol., May 1, 2009; 27(13): 2253 - 2260.
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 Arch OphthalmolHome page
P. N. Dayani, J. E. Gould, D. B. Brown, K. V. Sharma, G. P. Linette, and J. W. Harbour
Hepatic Metastasis From Uveal Melanoma: Angiographic Pattern Predictive of Survival After Hepatic Arterial Chemoembolization
Arch Ophthalmol, May 1, 2009; 127(5): 628 - 632.
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 Ann OncolHome page
H. L. West, H. A. Wakelee, M. C. Perry, R. J. Belt, R. Chen, and C. Obasaju
Gemcitabine and pemetrexed administered in rapid sequence as front-line chemotherapy for advanced non-small-cell lung cancer: a phase II clinical trial
Ann. Onc., May 1, 2009; 20(5): 850 - 856.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
D. Y. Zang, B. H. Lee, H.-C. Park, H. H. Song, H. J. Kim, J. Y. Jung, J. H. Kim, H. Y. Kim, J. H. Kwon, S. W. Hwang, et al.
Phase II study with oxaliplatin and S-1 for patients with metastatic colorectal cancer
Ann. Onc., May 1, 2009; 20(5): 892 - 896.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
K. Takeda, S. Negoro, T. Tamura, Y. Nishiwaki, S. Kudoh, S. Yokota, K. Matsui, H. Semba, K. Nakagawa, Y. Takada, et al.
Phase III trial of docetaxel plus gemcitabine versus docetaxel in second-line treatment for non-small-cell lung cancer: results of a Japan Clinical Oncology Group trial (JCOG0104)
Ann. Onc., May 1, 2009; 20(5): 835 - 841.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
I. Chau, A. R. Norman, D. Cunningham, J. Oates, R. Hawkins, T. Iveson, M. Nicolson, P. Harper, M. Seymour, and T. Hickish
The impact of primary tumour origins in patients with advanced oesophageal, oesophago-gastric junction and gastric adenocarcinoma--individual patient data from 1775 patients in four randomised controlled trials
Ann. Onc., May 1, 2009; 20(5): 885 - 891.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
K. -L. Garm Spindler, N. Pallisgaard, A. A. Rasmussen, J. Lindebjerg, R. F. Andersen, D. Cruger, and A. Jakobsen
The importance of KRAS mutations and EGF61A>G polymorphism to the effect of cetuximab and irinotecan in metastatic colorectal cancer
Ann. Onc., May 1, 2009; 20(5): 879 - 884.
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 JNMHome page
J. H. Lee, E. L. Rosen, and D. A. Mankoff
The Role of Radiotracer Imaging in the Diagnosis and Management of Patients with Breast Cancer: Part 2--Response to Therapy, Other Indications, and Future Directions
J. Nucl. Med., May 1, 2009; 50(5): 738 - 748.
[Abstract] [Full Text] [PDF]

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 Anticancer ResHome page
Y. ITANI, K. HOSOKAWA, K. ITO, S. TAKEUCHI, T. TABATA, H. TSUBAMOTO, H. FUJITA, M. AKIYAMA, and S. ADACHI
A Phase I/II Study of Docetaxel and Gemcitabine Combination for Chemotherapy-resistant Ovarian Cancer
Anticancer Res, May 1, 2009; 29(5): 1521 - 1526.
[Abstract] [Full Text] [PDF]

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 Anticancer ResHome page
M.-S. VUORISTO, P. VIHINEN, T. SKYTTA, K. TYYNELA, and P. KELLOKUMPU-LEHTINEN
Carboplatin and Vinorelbine Combined with Subcutaneous Interleukin-2 in Metastatic Melanoma with Poor Prognosis
Anticancer Res, May 1, 2009; 29(5): 1755 - 1759.
[Abstract] [Full Text] [PDF]

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 JNMHome page
L.-F. de Geus-Oei, D. Vriens, H. W.M. van Laarhoven, W. T.A. van der Graaf, and W. J.G. Oyen
Monitoring and Predicting Response to Therapy with 18F-FDG PET in Colorectal Cancer: A Systematic Review
J. Nucl. Med., May 1, 2009; 50(Suppl_1): 43S - 54S.
[Abstract] [Full Text] [PDF]

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 JNMHome page
R. L. Wahl, H. Jacene, Y. Kasamon, and M. A. Lodge
From RECIST to PERCIST: Evolving Considerations for PET Response Criteria in Solid Tumors
J. Nucl. Med., May 1, 2009; 50(Suppl_1): 122S - 150S.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
G. Liu, W. K. Kelly, G. Wilding, L. Leopold, K. Brill, and B. Somer
An Open-Label, Multicenter, Phase I/II Study of Single-Agent AT-101 in Men with Castrate-Resistant Prostate Cancer
Clin. Cancer Res., May 1, 2009; 15(9): 3172 - 3176.
[Abstract] [Full Text] [PDF]

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 JNMHome page
W. A. Weber
Assessing Tumor Response to Therapy
J. Nucl. Med., May 1, 2009; 50(Suppl_1): 1S - 10S.
[Abstract] [Full Text] [PDF]

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 JNMHome page
N. Avril, S. Sassen, and R. Roylance
Response to Therapy in Breast Cancer
J. Nucl. Med., May 1, 2009; 50(Suppl_1): 55S - 63S.
[Abstract] [Full Text] [PDF]

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 JNMHome page
M. P.S. Dunphy and J. S. Lewis
Radiopharmaceuticals in Preclinical and Clinical Development for Monitoring of Therapy with PET
J. Nucl. Med., May 1, 2009; 50(Suppl_1): 106S - 121S.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
T. W. Kim, M.-H. Ryu, H. Lee, S. J. Sym, J.-L. Lee, H. M. Chang, Y. S. Park, K. H. Lee, W. K. Kang, D. B. Shin, et al.
Kinase Mutations and Efficacy of Imatinib in Korean Patients with Advanced Gastrointestinal Stromal Tumors
Oncologist, May 1, 2009; 14(5): 540 - 547.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
F. Grossi, M. Aita, C. Defferrari, F. Rosetti, A. Brianti, G. Fasola, O. Vinante, P. Pronzato, and G. Pappagallo
Impact of Third-Generation Drugs on the Activity of First-Line Chemotherapy in Advanced Non-Small Cell Lung Cancer: A Meta-Analytical Approach
Oncologist, May 1, 2009; 14(5): 497 - 510.
[Abstract] [Full Text] [PDF]

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 JCOHome page
J. R. Eckardt, D. L. Bentsion, O. N. Lipatov, I. S. Polyakov, F. R. MacKintosh, D. A. Karlin, G. S. Baker, and H. B. Breitz
Phase II Study of Picoplatin As Second-Line Therapy for Patients With Small-Cell Lung Cancer
J. Clin. Oncol., April 20, 2009; 27(12): 2046 - 2051.
[Abstract] [Full Text] [PDF]

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 JCOHome page
T. Tanvetyanon, T. Padhya, J. McCaffrey, W. Zhu, D. Boulware, R. DeConti, and A. Trotti
Prognostic Factors for Survival After Salvage Reirradiation of Head and Neck Cancer
J. Clin. Oncol., April 20, 2009; 27(12): 1983 - 1991.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
M. R. Benz, J. Czernin, M. S. Allen-Auerbach, W. D. Tap, S. M. Dry, D. Elashoff, K. Chow, V. Evilevitch, J. J. Eckardt, M. E. Phelps, et al.
FDG-PET/CT Imaging Predicts Histopathologic Treatment Responses after the Initial Cycle of Neoadjuvant Chemotherapy in High-Grade Soft-Tissue Sarcomas
Clin. Cancer Res., April 15, 2009; 15(8): 2856 - 2863.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
Y. Kuang, A. Rogers, B. Y. Yeap, L. Wang, M. Makrigiorgos, K. Vetrand, S. Thiede, R. J. Distel, and P. A. Janne
Noninvasive Detection of EGFR T790M in Gefitinib or Erlotinib Resistant Non-Small Cell Lung Cancer
Clin. Cancer Res., April 15, 2009; 15(8): 2630 - 2636.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
J. A. Sparano, S. Moulder, A. Kazi, D. Coppola, A. Negassa, L. Vahdat, T. Li, C. Pellegrino, S. Fineberg, P. Munster, et al.
Phase II Trial of Tipifarnib plus Neoadjuvant Doxorubicin-Cyclophosphamide in Patients with Clinical Stage IIB-IIIC Breast Cancer
Clin. Cancer Res., April 15, 2009; 15(8): 2942 - 2948.
[Abstract] [Full Text] [PDF]

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 JCOHome page
A. A. Miller, D. J. Murry, K. Owzar, D. R. Hollis, E. B. Kennedy, G. Abou-Alfa, A. Desai, J. Hwang, M. A. Villalona-Calero, E. C. Dees, et al.
Phase I and Pharmacokinetic Study of Sorafenib in Patients With Hepatic or Renal Dysfunction: CALGB 60301
J. Clin. Oncol., April 10, 2009; 27(11): 1800 - 1805.
[Abstract] [Full Text] [PDF]

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 JCOHome page
J. Maurel, A. Lopez-Pousa, R. de las Penas, J. Fra, J. Martin, J. Cruz, A. Casado, A. Poveda, J. Martinez-Trufero, C. Balana, et al.
Efficacy of Sequential High-Dose Doxorubicin and Ifosfamide Compared With Standard-Dose Doxorubicin in Patients With Advanced Soft Tissue Sarcoma: An Open-Label Randomized Phase II Study of the Spanish Group for Research on Sarcomas
J. Clin. Oncol., April 10, 2009; 27(11): 1893 - 1898.
[Abstract] [Full Text] [PDF]

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 JCOHome page
R. Adam, D. A. Wicherts, R. J. de Haas, O. Ciacio, F. Levi, B. Paule, M. Ducreux, D. Azoulay, H. Bismuth, and D. Castaing
Patients With Initially Unresectable Colorectal Liver Metastases: Is There a Possibility of Cure?
J. Clin. Oncol., April 10, 2009; 27(11): 1829 - 1835.
[Abstract] [Full Text] [PDF]

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 JCOHome page
J. S. W. Stewart, E. E.W. Cohen, L. Licitra, C. M.L. Van Herpen, C. Khorprasert, D. Soulieres, P. Vodvarka, D. Rischin, A. M. Garin, F. R. Hirsch, et al.
Phase III Study of Gefitinib 250 Compared With Intravenous Methotrexate for Recurrent Squamous Cell Carcinoma of the Head and Neck
J. Clin. Oncol., April 10, 2009; 27(11): 1864 - 1871.
[Abstract] [Full Text] [PDF]

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 Am J Clin PatholHome page
G. Sartori, A. Cavazza, A. Sgambato, A. Marchioni, F. Barbieri, L. Longo, M. Bavieri, B. Murer, E. Meschiari, S. Tamberi, et al.
EGFR and K-ras Mutations Along the Spectrum of Pulmonary Epithelial Tumors of the Lung and Elaboration of a Combined Clinicopathologic and Molecular Scoring System to Predict Clinical Responsiveness to EGFR Inhibitors
Am J Clin Pathol, April 1, 2009; 131(4): 478 - 489.
[Abstract] [Full Text] [PDF]

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 Jpn J Clin OncolHome page
K. Tanaka, H. Kawamoto, I. Saito, K. Yoshimura, H. Fukuda, and Y. Iwamoto
Preoperative and Postoperative Chemotherapy with Ifosfamide and Adriamycin for Adult High-grade Soft-tissue Sarcomas in the Extremities: Japan Clinical Oncology Group Study JCOG0304
Jpn. J. Clin. Oncol., April 1, 2009; 39(4): 271 - 273.
[Abstract] [Full Text] [PDF]

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 Jpn J Clin OncolHome page
N. Yamamoto, Y. Yamada, Y. Fujiwara, K. Yamada, Y. Fujisaka, T. Shimizu, and T. Tamura
Phase I and Pharmacokinetic Study of HER2-targeted rhuMAb 2C4 (Pertuzumab, RO4368451) in Japanese Patients with Solid Tumors
Jpn. J. Clin. Oncol., April 1, 2009; 39(4): 260 - 266.
[Abstract] [Full Text] [PDF]

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 JCOHome page
R. T. Kloos, M. D. Ringel, M. V. Knopp, N. C. Hall, M. King, R. Stevens, J. Liang, P. E. Wakely Jr, V. V. Vasko, M. Saji, et al.
Phase II Trial of Sorafenib in Metastatic Thyroid Cancer
J. Clin. Oncol., April 1, 2009; 27(10): 1675 - 1684.
[Abstract] [Full Text] [PDF]

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 JCOHome page
M. T. Lee, J. J. Kim, R. Dinniwell, J. Brierley, G. Lockwood, R. Wong, B. Cummings, J. Ringash, R. V. Tse, J. J. Knox, et al.
Phase I Study of Individualized Stereotactic Body Radiotherapy of Liver Metastases
J. Clin. Oncol., April 1, 2009; 27(10): 1585 - 1591.
[Abstract] [Full Text] [PDF]

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 RadiologyHome page
M. A. Gavrielides, L. M. Kinnard, K. J. Myers, and N. Petrick
Noncalcified Lung Nodules: Volumetric Assessment with Thoracic CT
Radiology, April 1, 2009; 251(1): 26 - 37.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
T. Li, P. J. Christos, J. A. Sparano, D. L. Hershman, S. Hoschander, K. O'Brien, J. J. Wright, and L. T. Vahdat
Phase II trial of the farnesyltransferase inhibitor tipifarnib plus fulvestrant in hormone receptor-positive metastatic breast cancer: New York Cancer Consortium Trial P6205
Ann. Onc., April 1, 2009; 20(4): 642 - 647.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
Y.-K. Kang, W.-K. Kang, D.-B. Shin, J. Chen, J. Xiong, J. Wang, M. Lichinitser, Z. Guan, R. Khasanov, L. Zheng, et al.
Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial
Ann. Onc., April 1, 2009; 20(4): 666 - 673.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
H. R. Kim, S. Y. Rha, S. H. Cheon, J. K. Roh, Y. N. Park, and N. C. Yoo
Clinical features and treatment outcomes of advanced stage primary hepatic angiosarcoma
Ann. Onc., April 1, 2009; 20(4): 780 - 787.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
A. A. Lissoni, N. Colombo, A. Pellegrino, G. Parma, P. Zola, D. Katsaros, S. Chiari, A. Buda, F. Landoni, M. Peiretti, et al.
A phase II, randomized trial of neo-adjuvant chemotherapy comparing a three-drug combination of paclitaxel, ifosfamide, and cisplatin (TIP) versus paclitaxel and cisplatin (TP) followed by radical surgery in patients with locally advanced squamous cell cervical carcinoma: the Snap-02 Italian Collaborative Study
Ann. Onc., April 1, 2009; 20(4): 660 - 665.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
C. Falandry, P. A. Canney, G. Freyer, and L. Y. Dirix
Role of combination therapy with aromatase and cyclooxygenase-2 inhibitors in patients with metastatic breast cancer
Ann. Onc., April 1, 2009; 20(4): 615 - 620.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
P. Munster, D. Marchion, E. Bicaku, M. Lacevic, J. Kim, B. Centeno, A. Daud, A. Neuger, S. Minton, and D. Sullivan
Clinical and Biological Effects of Valproic Acid as a Histone Deacetylase Inhibitor on Tumor and Surrogate Tissues: Phase I/II Trial of Valproic acid and Epirubicin/FEC
Clin. Cancer Res., April 1, 2009; 15(7): 2488 - 2496.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
A. I. Daud, J. Dawson, R. C. DeConti, E. Bicaku, D. Marchion, S. Bastien, F. A. Hausheer III, R. Lush, A. Neuger, D. M. Sullivan, et al.
Potentiation of a Topoisomerase I Inhibitor, Karenitecin, by the Histone Deacetylase Inhibitor Valproic Acid in Melanoma: Translational and Phase I/II Clinical Trial
Clin. Cancer Res., April 1, 2009; 15(7): 2479 - 2487.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
K.-K. Wong, P. M. Fracasso, R. M. Bukowski, T. J. Lynch, P. N. Munster, G. I. Shapiro, P. A. Janne, J. P. Eder, M. J. Naughton, M. J. Ellis, et al.
A Phase I Study with Neratinib (HKI-272), an Irreversible Pan ErbB Receptor Tyrosine Kinase Inhibitor, in Patients with Solid Tumors
Clin. Cancer Res., April 1, 2009; 15(7): 2552 - 2558.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
Y. J. Lee, A. Cho, B. C. Cho, M. Yun, S. K. Kim, J. Chang, J. W. Moon, I. K. Park, H. J. Choi, and J.-H. Kim
High Tumor Metabolic Activity as Measured by Fluorodeoxyglucose Positron Emission Tomography Is Associated with Poor Prognosis in Limited and Extensive Stage Small-Cell Lung Cancer
Clin. Cancer Res., April 1, 2009; 15(7): 2426 - 2432.
[Abstract] [Full Text] [PDF]

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 JCOHome page
A. B. Sandler, J. H. Schiller, R. Gray, I. Dimery, J. Brahmer, M. Samant, L. I. Wang, and D. H. Johnson
Retrospective Evaluation of the Clinical and Radiographic Risk Factors Associated With Severe Pulmonary Hemorrhage in First-Line Advanced, Unresectable Non-Small-Cell Lung Cancer Treated With Carboplatin and Paclitaxel Plus Bevacizumab
J. Clin. Oncol., March 20, 2009; 27(9): 1405 - 1412.
[Abstract] [Full Text] [PDF]

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 JCOHome page
M. G. Teneriello, P. C. Tseng, M. Crozier, C. Encarnacion, K. Hancock, M. J. Messing, K. A. Boehm, A. Williams, and L. Asmar
Phase II Evaluation of Nanoparticle Albumin-Bound Paclitaxel in Platinum-Sensitive Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer
J. Clin. Oncol., March 20, 2009; 27(9): 1426 - 1431.
[Abstract] [Full Text] [PDF]

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 JCOHome page
D. R. Feldman, M. S. Baum, M. S. Ginsberg, H. Hassoun, C. D. Flombaum, S. Velasco, P. Fischer, E. Ronnen, N. Ishill, S. Patil, et al.
Phase I Trial of Bevacizumab Plus Escalated Doses of Sunitinib in Patients With Metastatic Renal Cell Carcinoma
J. Clin. Oncol., March 20, 2009; 27(9): 1432 - 1439.
[Abstract] [Full Text] [PDF]

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 JCOHome page
P. D. Cole, C. L. Schwartz, R. A. Drachtman, P. A. de Alarcon, L. Chen, and T. M. Trippett
Phase II Study of Weekly Gemcitabine and Vinorelbine for Children With Recurrent or Refractory Hodgkin's Disease: A Children's Oncology Group Report
J. Clin. Oncol., March 20, 2009; 27(9): 1456 - 1461.
[Abstract] [Full Text] [PDF]


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