New guidelines to evaluate the response to treatment in solid tumors

Therasse, Patrick; Arbuck, Susan G.; Eisenhauer, Elizabeth; Wanders, J.; Kaplan, Richard; Rubinstein, Larry; Verweij, Jaap; Glabbeke, M. van; Oosterom, A.T. van; Christian, Michaele C.; Gwyther, Steve G.

doi:10.1007/bf02967383

Cited by 1,121 publications

(1,451 citation statements)

References 5 publications

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“…A change in tumour volume at the end of treatment, PC 0F (V), exceeding À65% was taken as the cutoff between partial response (PR) and stable disease (SD), this being equivalent to a decrease in cross-sectional area of 50%, itself broadly equivalent to the RECIST criterion of a 50% decrease in the product of maximum orthogonal diameters (Therasse et al, 2000). No attempt was made to predict final tumour size in this study, as this is not likely to alter patient management before surgery.…”

Section: Quantifying and Correlating Parameter Changes And Tumour Resmentioning

confidence: 99%

Neoadjuvant chemotherapy in breast cancer: early response prediction with quantitative MR imaging and spectroscopy

et al. 2006

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A prospective study was undertaken in women undergoing neoadjuvant chemotherapy for locally advanced breast cancer in order to determine the ability of quantitative magnetic resonance imaging (MRI) and proton spectroscopy (MRS) to predict ultimate tumour response (percentage decrease in volume) or to detect early response. Magnetic resonance imaging and MRS were carried out before treatment and after the second of six treatment cycles. Pharmacokinetic parameters were derived from T 1 -weighted dynamic contrast-enhanced MRI, water apparent diffusion coefficient (ADC) was measured, and tissue water : fat peak area ratios and water T 2 were measured using unsuppressed one-dimensional proton spectroscopic imaging (30 and 135 ms echo times). Pharmacokinetic parameters and ADC did not detect early response; however, early changes in water : fat ratios and water T 2 (after cycle two) demonstrated substantial prognostic efficacy. Larger decreases in water T 2 accurately predicted final volume response in 69% of cases (11/16) while maintaining 100% specificity and positive predictive value. Small/absent decreases in water : fat ratios accurately predicted final volume non-response in 50% of cases (3/6) while maintaining 100% sensitivity and negative predictive value. This level of accuracy might permit clinical application where early, accurate prediction of non-response would permit an early change to second-line treatment, thus sparing patients unnecessary toxicity, psychological morbidity and delay of initiation of effective treatment.

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Section: Quantifying and Correlating Parameter Changes And Tumour Resmentioning

confidence: 99%

Neoadjuvant chemotherapy in breast cancer: early response prediction with quantitative MR imaging and spectroscopy

et al. 2006

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“…During treatment, assessments were repeated every three weeks while a complete blood count was carried out weekly (twice weekly in cycle 1). Investigator assessment of response was performed every two cycles according to RECIST criteria (Therasse et al, 2000). Adverse events were evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0.…”

Section: Study Investigationsmentioning

confidence: 99%

Multicentre phase II pharmacokinetic and pharmacodynamic study of OSI-7904L in previously untreated patients with advanced gastric or gastroesophageal junction adenocarcinoma

et al. 2006

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A two-stage Simon design was used to evaluate the response rate of OSI-7904L, a liposome encapsulated thymidylate synthase inhibitor, in advanced gastric and/or gastroesophageal adenocarcinoma (A-G/GEJA), administered intravenously at 12 mg m À2 over 30 min every 21 days. Fifty patients were treated. Median age was 64 years (range 35 -82), 62% were male and 89% had ECOG PS of 0/1. A total of 252 cycles were administered; median of 4 per patient (range 1 -21). Twelve patients required dose reductions, mainly for skin toxicity. Investigator assessed response rate was 17.4% (95% CI 7.8 -31.4) with one complete and seven partial responses in 46 evaluable patients. Twenty-one patients (42%) had stable disease. Median time to progression and survival were 12.4 and 36.9 weeks, respectively. NCI CTCAE Grade 3/4 neutropenia (14%) and thrombocytopenia (4%) were uncommon. The main G3/4 nonhaematological toxicities were skin-related 22%, stomatitis 14%, fatigue/lethargy 10%, and diarrhea 8%. Pharmacokinetic data showed high interpatient variability. Patients with higher AUC were more likely to experience G3/4 toxicity during cycle 1 while baseline homocysteine did not predict toxicity. Response did not correlate with AUC. Elevations in 2 0 -dU were observed indicating target inhibition. Analysis of TS genotype, TS protein and expression did not reveal any correlation with outcome. OSI-7904L has activity in A-G/GEJA similar to other active agents and an acceptable safety profile.

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“…every 8 weeks). Responses were defined according to the RECIST criteria (Therasse et al, 2000) except for the patient with Kaposi's sarcoma, whose response was defined according to the criteria used by the World Health Association (WHO Handbook, 1979).…”

Section: Treatment Planmentioning

confidence: 99%

Phase I study of pegylated liposomal doxorubicin and the multidrug-resistance modulator, valspodar

Fracasso¹,

Blum²,

K.³

et al. 2005

Br J Cancer

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Valspodar, a P-glycoprotein modulator, affects pharmacokinetics of doxorubicin when administered in combination, resulting in doxorubicin dose reduction. In animal models, valspodar has minimal interaction with pegylated liposomal doxorubicin (PEG-LD). To determine any pharmacokinetic interaction in humans, we designed a study to determine maximum tolerated dose, dose-limiting toxicity (DLT), and pharmacokinetics of total doxorubicin, in PEG-LD and valspodar combination therapy in patients with advanced malignancies. Patients received PEG-LD 20 -25 mg m À2 intravenously over 1 h for cycle one. In subsequent 2-week cycles, valspodar was administered as 72 h continuous intravenous infusion with PEG-LD beginning at 8 mg m À2 and escalated in an accelerated titration design to 25 mg m À2 . Pharmacokinetic data were collected with and without valspodar. A total of 14 patients completed at least two cycles of therapy. No DLTs were observed in six patients treated at the highest level of PEG-LD 25 mg m À2 . The most common toxicities were fatigue, nausea, vomiting, mucositis, palmar plantar erythrodysesthesia, diarrhoea, and ataxia. Partial responses were observed in patients with breast and ovarian carcinoma. The mean (range) total doxorubicin clearance decreased from 27 (10 -73) ml h À1 m À2 in cycle 1 to 18 (3 -37) ml h À1 m À2 with the addition of valspodar in cycle 2 (P ¼ 0.009). Treatment with PEG-LD 25 mg m À2 in combination with valspodar results in a moderate prolongation of total doxorubicin clearance and half-life but did not increase the toxicity of this agent.

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New guidelines to evaluate the response to treatment in solid tumors

Cited by 1,121 publications

References 5 publications

Neoadjuvant chemotherapy in breast cancer: early response prediction with quantitative MR imaging and spectroscopy

Neoadjuvant chemotherapy in breast cancer: early response prediction with quantitative MR imaging and spectroscopy

Multicentre phase II pharmacokinetic and pharmacodynamic study of OSI-7904L in previously untreated patients with advanced gastric or gastroesophageal junction adenocarcinoma

Phase I study of pegylated liposomal doxorubicin and the multidrug-resistance modulator, valspodar

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