^
Association details:
Evidence:
Evidence Level:
Sensitive: B - Late Trials
Title:

Wild-Type KRAS Is Required for Panitumumab Efficacy in Patients With Metastatic Colorectal Cancer

Published date:
06/14/2023
Excerpt:
The treatment effect on PFS in the wild-type (WT) KRAS group (hazard ratio [HR], 0.45; 95% CI: 0.34 to 0.59) was significantly greater (P < .0001) than in the mutant group (HR, 0.99; 95% CI, 0.73 to 1.36)....WT KRAS patients had longer overall survival (HR, 0.67; 95% CI, 0.55 to 0.82; treatment arms combined)….Panitumumab monotherapy efficacy in mCRC is confined to patients with WT KRAS tumors.
DOI:
10.1200/JCO.22.02758
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study of Perioperative Chemotherapy Plus Panitumumab in Patients With Colorectal Cancer Liver Metastases

Excerpt:
...To evaluate the objective response rate (ORR) to preoperative FOLFOX/FOLFIRI plus panitumumab (by RECIST criteria) in patients with wild type KRAS.`...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Dual Epidermal Growth Factor Receptor Inhibition With Erlotinib and Panitumumab With or Without Chemotherapy for Advanced Colorectal Cancer

Excerpt:
...- Tumor expressing wild-type Kras mutations...
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

VECTIBIX PLUS OXALIPLATIN-BASED ADJUVANT TREATMENT OF RECTAL CANCER

Excerpt:
...All the following must be met• Written Informed consent• Adult patients with resected rectal cancer, stage 2 and 3• Wild-type kRAS tumor status• Age > 18• Adequate PS <2• Resection of rectal cancer preceded by chemo-irradiation; there should be at least 3 weeks of postoperative recovery allowed before initiation of adjuvant treatment. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Multizentrische Phase 2-Studie zur neoadjuvanten Radiochemotherapie in Kombination mit Panitumumab bei lokal fortgeschrittenem Rektumkarzinom mit Nachweis von KRAS Wild-Typ (NEOREC-1-Studie)

Excerpt:
...o Histologically confirmed, potentially resectable rectal adenocarcinoma staged as uT3/4 N0/1 by endosonography or cT3/4 by MRI of the pelvis with or without local lymph node metastases.o Wild-type KRAS.o ECOG-performance status 0 or 1.o Age ≥ 18 years.o Laboratory requirements:- Haematology: Leucocyte count > 3,000/mm³, neutrophil count ≥1.5x109/L, hemoglobin ≥ 8 g/dL, platelet count ≥100x109/L.- Hepatic Function: Total bilirubin ≤ 1.5 time the upper normal limit (UNL), ASAT ≤ 2.5xUNL in absence of liver metastases or ≤ 5xUNL in presence of liver metastases, ALAT ≤ 2.5xUNL in absence of liver metastases or ≤ 5xUNL in presence of liver metastases- Renal Function: Creatinine clearance ≥50 mL/min or serum creatinine ≤1.5xUNL- Metabolic Function: Magnesium ≥ lower limit of normal, Calcium ≥ lower limit of normal.o Negative ß-HCG-serum pregnancy test (females of child bearing potential).o Willing to use double-barrier contraception during study and for 6 months after the end of treatment. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Phase II study of pre-operative treatment with external radiotherapy plus panitumumab in operable locally advanced rectal cancer (favourable and intermediate prognostic group) (RaP Study/STAR-03) Studio di fase II sul trattamento pre-operatorio con radioterapia esterna e panitumumab in pazienti con tumore del retto in stadio localmente avanzato, operabile, a prognosi favorevole o intermedia (Studio RaP/STAR-03)

Excerpt:
...Histologically diagnosis of adenocarcinoma of the mid-low rectum (within 12 cm from the anal verge); KRAS wild type; age ≥18 years; Karnofsky performance status of ≥70 at study entry; clinical stage T3 N- M0 or cT2-T3 N+ M0 - CRM; hemoglobin ≥ 9 g/dl; neutrophils ≥ 1.5 x 10^9/L; platelets ≥ 100 x 10^9/L; bilirubin level < 1.5 ULN; ASAT and ALAT <= 2.5 x ULN; serum creatinine < 1.5 x ULN; magnesium ≥ lower limit of normal; calcium ≥ lower limit of normal; effective contraception for both, male and female patients if the risk of conception exists; signed and dated written informed consents Diagnosi Istologica di adenocarcinoma del retto medio-basso (entro 12 cm dal margine anale); KRAS wild-type; Età≥ 18 anni; Karnofsky performance status ≥70 all'inizio dello studio; stadio clinico T3 N-M0 o CT2-T3 N + M0 - CRM; emoglobina ≥ 9 g / dl; neutrofili ≥1,5 x 10^9 / L; piastrine ≥ 100 x 10^9 / L; livello di bilirubina <1,5 ULN; ASAT e ALAT <= 2,5 x ULN; creatinina sierica < 1,5 x ULN; magnesio ≥ limite inferiore del normale; calcio ≥ limite inferiore del normale; contraccettivo efficace per entrambi, pazienti maschi e femmine se il rischio di concepimento esiste; consenso informato scritto firmato e datato....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Safety and Efficacy Study of mFOLFOX6 + Panitumumab Combination Therapy and 5-FU/LV + Panitumumab Combination Therapy in Participants With Chemotherapy-naïve Unresectable Advanced Recurrent Colorectal Carcinoma

Excerpt:
...Participants classified as KRAS wild-type....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

SPIRITT - Second-Line Panitumumab Irinotecan Treatment Trial

Excerpt:
...- Wild-type KRAS expressing mCRC from the primary tumor or metastasis....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study Assessing Potential Predictive Tumor Markers in Metastatic Colorectal Cancer

Excerpt:
...To estimate the PFS by DP immunohistochemistry (IHC) expression in patients with wild-type KRAS mCRC treated with panitumumab and mFOLFOX6. ...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study to Evaluate Real-world Pharmacoeconomics of Panitumumab in Metastatic Colorectal Cancer Patients

Excerpt:
...- Patients with a wt KRAS scheduled to receive panitumumab as a single agent for the third-line treatment of mCRC or patients with a mt KRAS scheduled to receive SOC for third-line treatment of mCRC....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study to Evaluate Real-world Pharmacoeconomics and Resistance Mechanisms of Panitumumab in Metastatic Colorectal Cancer Patients

Excerpt:
...- Patients with a wt KRAS scheduled to receive panitumumab as a single agent for the third-line treatment of mCRC or patients with a mt KRAS scheduled to receive SOC for third-line treatment of mCRC....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Safety Study of the Combination of Panitumumab, Irinotecan and Everolimus in the Treatment of Advanced Colorectal Cancer

Excerpt:
...- Histological diagnosis of colorectal cancer that is KRAS wild type...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Go to data
Title:

Safety and Efficacy Study of FOLFOX4+Panitumumab vs.FOLFIRI+Panitumumab in Subjects WT KRAS Colorectal Cancer and Liver-only Metastases

Excerpt:
...- Wild Type KRAS status...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Panitumumab for Intravenous Infusion 100 mg and 400 mg Special Drug Use Surveillance "Survey on Unresectable, Advanced or Recurrent Colorectal Cancer With Wild-type KRAS Gene" (All-patient Surveillance)

Excerpt:
...- Unresectable, advanced or recurrent colorectal cancer with wild-type KRAS gene...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Phase I/II Study for the Safety and Efficacy of Panitumumab in Combination With TAS-102 for Patients With Colorectal Cancer

Excerpt:
...Participants classified as KRAS/NRAS wild-type** by KRAS/NRAS testing*....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Comparison of Two Preemptive Treatment Strategies of Panitumumab Mediated Skin Toxicity and Assessment of QoL in Patient With Ras-wt Colorectal Cancer

Excerpt:
...Patients with wild-type RAS (KRAS and NRAS) status of metastatic colorectal cancer treatment with panitumumab according to label...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study to Evaluate Mechanisms of Acquired Resistance to Panitumumab

Excerpt:
...- Subjects with wild-type KRAS tumor status confirmed by an Amgen approved central laboratory assessment or an experienced local laboratory assessment of archival tumor tissue (preferably from the primary tumor);...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Panitumumab in Combination With Radiotherapy in Patients With Locally Advanced RAS Wildtype Rectal Cancer (Clinical Stages II and III)

Excerpt:
......
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

SKIP - A Double-blind Placebo-controlled Randomized Multicenter Trial of Skin Toxicity Treatment

Excerpt:
...Patients with advanced or metastatic colorectal cancer (mCRC) and non-mutated (wild-type) KRAS who are planned to receive treatment with panitumumab monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens and without prior treatment with epidermal growth factor receptor (EGFR) antibody 2....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Preoperative Panitumumab and Radiotherapy in Rectal Cancer

Excerpt:
...- Wild-type KRAS...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

FOLFOXIRI Plus Panitumumab Patients With Metastatic KRAS Wild-Type Colorectal Cancer With Liver Metastases Only

Excerpt:
...Tumor tissue must reveal wild-type KRAS expression (i.e....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Neoadjuvant Radiochemotherapy Combined With Panitumumab in Locally Advanced KRAS Wild-type Rectal Cancer

Excerpt:
...- Wild-type KRAS....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

FOLFOXIRI Plus Panitumumab In Kras and Braf Wild-Type Metastatic Colorectal Cancer

Excerpt:
...- KRAS and BRAF wild-type status of primary colorectal cancer or related metastasis;...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

KRAS Wild-type Metastatic Colorectal Cancer Trial

Excerpt:
...Tumor is KRAS wild-type....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study to Evaluate the Effects of Panitumumab if Combined With Chemotherapy for 2nd Treatment of Colorectal Cancer

Excerpt:
...Progression-free survival rate at 6 months for subjects with KRAS wild-type tumours...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Panitumumab After Resection of Liver Metastases From Colorectal Cancer in KRAS Wild-type Patients

Excerpt:
...- KRAS-wildtype of the tumor...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Clinical Trial of Panitumumab in Combination With FOLFIRI Chemotherapy as Second Line Treatment in Subjects With Metastatic Colorectal Cancer Expressing Wild-type KRAS and Who Had Progressed ≥ 6 Months After the Last Dose of the First Line Chemotherapy

Excerpt:
...- Subjects with wild-type KRAS tumor status confirmed by central laboratory assessment of paraffin-embedded tumor tissue from the primary tumor or metastasis....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Panitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC

Excerpt:
...Patients classified as KRAS/NRAS wild-type by KRAS/NRAS testing....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

FOLFOXIRI Plus Panitumumab in Metastatic RAS Wild-type, Left-sided Colorectal Cancer

Excerpt:
......
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

FOLFOXIRI With or Without Panitumumab in Metastatic Colorectal Cancer (VOLFI)

Excerpt:
......
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

PEAK: Panitumumab Plus mFOLFOX6 vs. Bevacizumab Plus mFOLFOX6 for First Line Treatment of Metastatic Colorectal Cancer (mCRC) Patients With Wild-Type Kirsten Rat Sarcoma-2 Virus (KRAS) Tumors

Excerpt:
...- Wild-type KRAS tumor status confirmed by an Amgen approved central laboratory or an experienced laboratory (local laboratory) per local regulatory guidelines using a validated test method...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer

Excerpt:
...- Wild-type KRAS tumor status...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study of Tivantinib (ARQ 197) Plus Cetuximab in EGFR Inhibitor-Resistant MET High Subjects

Excerpt:
...All subjects must express the wild-type form of the gene KRAS....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Panitumumab and Bortezomib for Patients With Advanced Colorectal Cancer

Excerpt:
...- KRAS wild-type colorectal cancer...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Phase IV Panitumumab Study in Indian Subjects With Metastatic Colorectal Cancer

Excerpt:
...- Wild-type KRAS (without mutation in exon 2 [codons 12 and 13], exon 3 [codons 59 and 61], and exon 4 [codons 117 and 146]) and wild-type NRAS (without mutation in exon 2 [codons 12 and 13], exon 3 [codons 59 and 61], and exon 4 [codons 117 and 146]) tumor status....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

FOLFOXIRI plus Panitumumab or FOLFOX plus Panitumumab in the treatment of metastatic colorectal cancer. folfoxiri più panitumumab contro folfox più panitumumab nel carcinoma del colonretto metastatico.

Excerpt:
...Histologically proven diagnosis of colorectal cancer.Initially unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease.At least one measurable lesion according to RECIST1.1Availability of a tissue tumour sample (primary tumour and/or metastatic sites)Previous adjuvant chemotherapy allowed only if with fluoropyrimidine monotherapy and more than 6 months elapsed between the end of adjuvant and first relapse.RAS (codons 12, 13, 59, 61, 117 and 146 of KRAS and NRAS genes) and BRAF (V600E mutation) wild type status of primary colorectal cancer or related metastasis (local or central laboratory assessment). ...
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Chemotherapy plus panitumumab/cetuximab versus chemotherapy plus bevacizumab in wild-type KRAS/RAS metastatic colorectal cancer: a meta-analysis

Published date:
11/14/2022
Excerpt:
Meta-analysis showed that EGFR inhibitors significantly prolonged the overall survival (OS) [HR = 0.83, 95%CI (0.73, 0.94), P = 0.003] and overall response rate (ORR) [RR = 1.11, 95%CI (1.05, 1.18), P = 0.0003] compared to VEGF inhibitors in wild-type KRAS/RAS mCRC patients... ​Our study showed that EGFR inhibitors were superior to VEGF inhibitors in wild-type KRAS/RAS mCRC patients, especially in patients with first-line treatment.
Secondary therapy:
Chemotherapy
DOI:
10.1080/14737140.2022.2147512
Evidence Level:
Sensitive: C3 – Early Trials
New
Source:
Title:

Tumour location and efficacy of first-line EGFR inhibitors in KRAS/RAS wild-type metastatic colorectal cancer: retrospective analyses of two phase II randomised Spanish TTD trials

Excerpt:
Patients with KRAS/RAS-wild type (wt) mCRC treated in first line with epidermal growth factor receptor inhibitors (EGFR-Is) (cetuximab or panitumumab) plus oxaliplatin or irinotecan...Patients with KRAS-wt right-sided tumours (n=52) had significantly lower efficacy as compared with patients with KRAS-wt left-sided tumours (n=209); confirmed ORR (25% vs 47%, respectively; OR 0.4, 95% CI 0.2 to 0.8, p=0.004); and shorter median PFS (7.2 vs 9.9 months; HR 0.6, 95% CI 0.4 to 0.9, p=0.0157) and OS (13.6 vs 27.7 months; HR 0.5, 95% CI 0.3 to 0.7, p<0.0001).... We observed significantly improved efficacy outcomes in patients with KRAS/RAS-wt mCRC treated with first-line EGFR-I plus chemotherapy in left-sided primary tumours as compared with right-sided primary tumours.
Secondary therapy:
irinotecan; oxaliplatin
DOI:
10.1136/esmoopen-2019-000599
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

FOLFIRI plus panitumumab in the treatment of wild-type KRAS and wild-type NRAS metastatic colorectal cancer

Excerpt:
The median overall survival (OS) was 26 months in the patients with wild-type KRAS and wild-type NRAS mCRC. It was 90.4% for the 6-month OS, 79.5% for the 1-year OS, 53.7% for the 2-year OS and 31.1% for the 3-year OS….The first-line FOLFIRI plus panitumumab was associated with favourable efficacy in the patients with wild-type KRAS and wild-type NRAS mCRC, and it was well tolerated.
Secondary therapy:
FOLFIRI
DOI:
10.1186/s12957-018-1359-9