Information on a possible treatment option for patients with advanced RCC¹

• The treatment of advanced RCC has evolved, and effective options for patients with disease refractory to kinase inhibitors such as sunitinib now exist
• A Phase III trial provides evidence of PFS prolongation by AFINITOR after progression on a VEGF-targeted agent such as sunitinib
• The AFINITOR pivotal trial is the first Phase III, prospective, randomized, double-blinded, placebo-controlled trial to demonstrate a clinical benefit after sunitinib or sorafenib failure

The most likely answer is All of the above.

Akin to second-line treatment, there are multiple factors to consider in the subsequent treatment of mRCC. Among these are comorbidities (e.g., hypertension), PS, previous therapy, the type and duration of progression, clinical efficacy and safety data of the proposed next agent, and other patient-related factors (e.g., insurance coverage, preference, concurrent therapies).^1-4

Oncologist's notes:

• Maria agreed to start sorafenib (400 mg PO BID); toxicity included Grade 2 hand-foot syndrome and mild diarrhea
• In addition, Maria's BP increased to 178/115 and required more aggressive management; sorafenib dose was decreased
• Follow up CT scans of the chest/abdomen at 3 months demonstrated stable disease with 15% decrease in several pulmonary nodules, and central necrosis in the right hilar mass
• Scans were repeated after 6 months' treatment and the pulmonary lesions were unchanged, however progressive disease in the liver with several new lesions was noted
• After 12 months' therapy (6 months IFN-α, 6 months of sorafenib), Maria was diagnosed with progressive disease
• Maria appeared shocked and in denial after hearing this diagnosis

The most likely answer is All of the above.

Clinicians have a host of clinical-, disease-, treatment-, and patient-related factors to consider when selecting second-line treatment of mRCC. These include but are not limited to comorbidities (e.g., hypertension), PS (e.g., Karnofsky, ECOG), previous therapy, the type and duration of progression, clinical efficacy and safety data of the proposed next agent, as well as individual patient factors (e.g., insurance coverage, costs, preference/lifestyle, concurrent therapies).^1-4

Oncologist's notes:

• Maria was treated with SC interferon-α (IFN-α) (9.0 MU TIW) for 24 weeks
• Toxicity with this therapy included Grade 3 fatigue, chills, fever and required dose reduction and delays
• Repeat CT scans of the chest/abdomen (week 24) demonstrated stable pulmonary nodules and several 1.0-cm enhancing liver lesions consistent with metastases
• After 6 months of IFN-α, patient was considered cytokine refractory, and additional treatment was presented to and discussed with the patient

Imaging study results:

Click on Maria's x-ray and CT scans to obtain results.

• Chest x-ray revealed multiple pulmonary nodules
• Bone scan and brain CT showed no evidence of metastases
• CT chest/abdomen/pelvis revealed the following:
• Bilateral multiple pulmonary nodules (largest 3.2 cm)
• Right hilar adenopathy
• Abdomen and pelvis: previous right nephrectomy, no evidence of metastases
• Bronchoscopy and needle biopsy: consistent with clear cell RCC

     

Laboratory report:

• WBC: 8.65 x 103/μL
• LDH: 350 U/L (ULN=625)
• Hb: 12.5 g/dL (LLN=12.0)
• Platelets: 286 x 103/μL
• Calcium: 9.0 mg/dL (corrected: 9.2 mg/dL)
• Serum creatinine: 0.9 mg/dL (ULN=1.4)

Internist's notes:

• Postnephrectomy (4 yrs), Maria presented with a chronic nonproductive cough
• Physical examination was unremarkable (ECOG PS=0)
• Ordered routine chest x-ray, which revealed enlarged right hilar lymph nodes and 4 bilateral pulmonary nodules (largest 3.0 cm)

Pathologist's report:

• An abdominal CT scan showed 5.5-cm right renal mass and a subsequent right nephrectomy was performed
• The pathology report indicated:
• 5.5-cm clear cell carcinoma
• Fuhrman Grade 2/4 with capsular invasion
• No lymph nodes identified