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Recently, the European Journal of Urology (EU) published a phase II multicenter single-arm trial evaluating the results of lenvatinib (Lenvatinib) combined with everolimus (Everolimus) in the treatment of patients with advanced nccRCC, showing that the treatment plan has Good anti-cancer activity, and safety is consistent with established safety
Research methods
Research Method Research Method| Inclusion criteria | Exclusion criteria |
|
Pathologically confirmed as nccRCC |
Previous exposure to lenvatinib or mTOR inhibitors |
|
Have not received relevant anti-cancer treatment |
Will undergo major surgery within three weeks of starting the medication |
|
ECOG PS score is 0 or 1 |
Uncontrollable diabetes |
|
Good blood pressure control |
Proteinuria (1g/24h) |
|
Liver, kidney, and bone marrow function are normal |
Interstitial lung disease |
|
Active non-infectious pneumonia |
|
|
Anything that affects the absorption of the study drug |
Previous exposure to lenvatinib or mTOR inhibitors
Will undergo major surgery within three weeks of starting the medication
Uncontrollable diabetes
Proteinuria (1g/24h)
Interstitial lung disease
Previous exposure to lenvatinib or mTOR inhibitors
Pathologically confirmed as nccRCC
Pathologically confirmed as nccRCC
Previous exposure to lenvatinib or mTOR inhibitors
Previous exposure to lenvatinib or mTOR inhibitors
Have not received relevant anti-cancer treatment
Will undergo major surgery within three weeks of starting the medication
Have not received relevant anti-cancer treatment
Have not received relevant anti-cancer treatment
Will undergo major surgery within three weeks of starting the medication
Will undergo major surgery within three weeks of starting the medication
ECOG PS score is 0 or 1
Uncontrollable diabetes
ECOG PS score is 0 or 1
ECOG PS score is 0 or 1
Uncontrollable diabetes
Uncontrollable diabetes
Good blood pressure control
Proteinuria (1g/24h)
Good blood pressure control
Good blood pressure control
Proteinuria (1g/24h)
Proteinuria (1g/24h)
Liver, kidney, and bone marrow function are normal
Interstitial lung disease
Liver, kidney, and bone marrow function are normal
Liver, kidney, and bone marrow function are normal
Interstitial lung disease
Interstitial lung disease
Active non-infectious pneumonia
Anything that affects the absorption of the study drug
drug
drugEnrolled patients received lenvatinib(18 mg orally, once a day) plus everolimus (5 mg orally, once a day) for 28 consecutive days, as long as there is evidence of clinical benefit, or until complications Disease, unacceptable toxicity, disease progression, or patient withdrawal from the study
Le Laval imatinib everolimus
Observation index
Observed indicators observed indicatorsMain result
Main resultObjective response rate (ORR): The objective response rate refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including cases of complete remission and partial remission
.
.
Secondary result
Secondary result1.
Progression-free survival (PFS) and overall survival (OS);
2.
The PFS and ORR of the independent imaging examination (IIR) are also used as exploratory endpoints (imaging examinations are performed every eight weeks);
3.
Clinical benefit rate (CBR, defined as complete remission, partial remission, or sustained [>23 weeks]] the proportion of patients with the best overall remission of stable disease);
4.
Disease control rate {DCR is defined as the proportion of patients with the best overall remission (complete remission, partial remission, or stable disease))}
.
5.
Safety Evaluate safety by monitoring and recording all adverse events
result
Result resultBasic situation of the patient
Basic situation of the patientThe study included 31 patients with nccRCC, and all patients received study treatment
.
Most patients had papillary renal cell carcinoma (n = 20/31; 65%), followed by chromophobe cell carcinoma (n = 9/31; 29%), unclassified (n = 2/31; 6%) nccRCC
.
Among the enrolled patients, the median age was 64 years, and about two-thirds were men (65%)
.
The ECOG PS of most patients was 0 (n = 23/31; 74%), and less than half of them had undergone nephrectomy (n = 11/31; 35%)
.
Lymph nodes are the most common site of metastasis (n = 22/31; 71%)
.
As of the data cutoff date (July 17, 2019), 6 patients (19%) are still on treatment, and 25 patients (81%) have stopped the study, including treatment of radiation or clinical disease progression (n = 15/31; 48 %), adverse events (n = 6/31; 19%), patients opted out (n = 4/31; 13%); but there are still 8 patients in the study follow-up
.
Treatment result
Treatment resultThe best overall response with partial response was observed in 8 patients, and no patient confirmed complete response
.
The researchers and IIR assessed the overall ORR of the patients were both 26% (95% CI 12-45)
.
According to the researchers' evaluation, 18 patients were in stable condition, and the DCR was 84%
.
In 11 patients, persistent (≥23 weeks) stable disease was observed, of which CBR (complete remission, partial remission or persistent stable) accounted for 61%
.
In contrast, the DCR and CBR of IIR are 71% and 52%, respectively
.
The median duration of response cannot be estimated (NE); however, according to IIR, the majority (88%) of responders (ie, complete or partial responders) lasted for 5 months
.
Among the 20 patients with papillary renal cell carcinoma, 3 patients had partial remission with an ORR of 15% (n = 3/20), and the other 14 patients were in stable condition with a DCR of 85% (n = 17/20, the researchers assessed )
.
Among the 4 patients with chromophobe cell carcinoma, the ORR was 44% (n = 4/9), and the other 3 patients were in stable condition with a DCR of 78% (n = 7/9; researcher's assessment)
.
Among the two unclassified ncccc patients in this study, one had a partial remission and one had a stable condition
.
The researchers assessed that the median PFS was 9.
2 months and the median OS was 15.
6 months (as shown in the figure below); through IIR, the median PFS was 5.
6 months
.
Safety results
Safety resultsAll patients experienced at least one treatment emergency adverse event ( TEAE )
.
.
The five most common TEAEs (any grade) are fatigue (71%), diarrhea (58%), decreased appetite (55%), nausea (55%) and vomiting (52%)
.
Events with TEAE ≥ grade 3 occurred in 68% of patients
.
.
Events with TEAE ≥ grade 3 occurred in 68% of patients
.
TEAEs led to drug withdrawal or withdrawal in 32% of patients (n = 10/31; 1 each for cardiac arrest, heart failure, arthralgia, back pain, cancer pain, hepatic encephalopathy, and tremor; 3 cases were malignant tumor progression)
.
.
TEAEs results in 45% (n = 14/31) to reduce the dosage to the patient (only music cutting imatinib ), 68% (n = 21/31 ) patients with drug interrupt ( Le Laval gefitinib and / or everolimus)
.
In general, music cutting erlotinib in patients relative dose intensity was 87% (range 32-100%), depending on the relative position of everolimus dose intensity was 94% (range 64-100%)
.
.
Treatment-related TEAEs occurred in 94% of patients, and 48% of patients had at least one grade ≥3 TEAE event; 3 fatal TEAEs (2 cases of malignant tumor progression and 1 case of cardiac arrest)
.
.
in conclusion
Conclusion conclusionThe combination drug showed good anti-cancer activity, the overall ORR rate was 26%, the median OS evaluated by the researchers was 15.
6 months, the median PFS was 9.
2 months, and the median PFS evaluated by the IIR was 5.
6 months
.
6 months, the median PFS was 9.
2 months, and the median PFS evaluated by the IIR was 5.
6 months
.
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