lunes, 26 de agosto de 2019

Childhood Non-Hodgkin Lymphoma Treatment (PDQ®) 6/8 –Health Professional Version - National Cancer Institute

Childhood Non-Hodgkin Lymphoma Treatment (PDQ®)–Health Professional Version - National Cancer Institute

National Cancer Institute



Childhood Non-Hodgkin Lymphoma Treatment (PDQ®)–Health Professional Version



Anaplastic Large Cell Lymphoma

Incidence

Anaplastic large cell lymphoma accounts for approximately 10% of childhood non-Hodgkin lymphoma (NHL) cases.[1] (Refer to Table 1 for more information about the incidence of anaplastic large cell lymphoma by age and sex distribution.)

Tumor Biology

While the predominant immunophenotype of anaplastic large cell lymphoma is mature T-cell, null-cell disease (i.e., no T-cell, B-cell, or natural killer-cell surface antigen expression) does occur. The World Health Organization (WHO) classifies anaplastic large cell lymphoma as a subtype of peripheral T-cell lymphoma.[2]
All anaplastic large cell lymphoma cases are CD30-positive. More than 90% of pediatric anaplastic large cell lymphoma cases have a chromosomal rearrangement involving the ALK gene. About 85% of these chromosomal rearrangements will be t(2;5)(p23;q35), leading to the expression of the fusion protein NPM-ALK; the other 15% of cases are composed of variant ALK translocations.[3] Anti-ALK immunohistochemical staining pattern is quite specific for the type of ALK translocation. Cytoplasm and nuclear ALK staining is associated with NPM-ALK fusion protein, whereas cytoplasmic staining only of ALK is associated with the variant ALK translocations, as shown in Table 6.[4]
Table 6. Variant ALK Translocation and Associated Partner Chromosome Location and Frequencya
Gene FusionPartner Chromosome LocationFrequency of Gene Fusion
aAdapted from Tsuyama et al.[4]
NPM-ALK5q36.1~80%
TPM3-ALK1p23~15%
ALO17-ALK17q25.3Rare
ATIC-ALK2q35Rare
CLTC-ALK17q23Rare
MSN-ALKXp11.1Rare
MYH9-ALK22q13.1Rare
TFG-ALK3q12.2Rare
TPM4-ALK19p13Rare
TRAF1-ALK9q33.2Rare
In adults, ALK-positive anaplastic large cell lymphoma is viewed differently from other peripheral T-cell lymphomas because prognosis tends to be superior.[5] Also, adult ALK-negative anaplastic large cell lymphoma patients have an inferior outcome compared with patients who have ALK-positive disease.[6] In children, however, this difference in outcome between ALK-positive and ALK-negative disease has not been demonstrated. In addition, no correlation has been found between outcome and the specific ALK-translocation type.[7-9]
In a European series of 375 children and adolescents with systemic ALK-positive anaplastic large cell lymphoma, the presence of a small cell or lymphohistiocytic component was observed in 32% of patients and was significantly associated with a high risk of failure in the multivariate analysis, controlling for clinical characteristics (hazard ratio, 2.0; P = .002).[8] The prognostic implication of the small cell variant of anaplastic large cell lymphoma was also shown in the COG-ANHL0131 (NCT00059839) study, despite a different chemotherapy backbone.[9]

Clinical Presentation

Clinically, systemic anaplastic large cell lymphoma has a broad range of presentations. These include involvement of lymph nodes and a variety of extranodal sites, particularly skin and bone and, less often, gastrointestinal tract, lung, pleura, and muscle. Involvement of the central nervous system (CNS) and bone marrow is uncommon.
Anaplastic large cell lymphoma is often associated with systemic symptoms (e.g., fever, weight loss) and a prolonged waxing and waning course, making diagnosis difficult and often delayed. Patients with anaplastic large cell lymphoma may present with signs and symptoms consistent with hemophagocytic lymphohistiocytosis.[10]
There is a subgroup of anaplastic large cell lymphoma patients who have leukemic peripheral blood involvement. These patients usually exhibit significant respiratory distress with diffuse lung infiltrates or pleural effusions and have hepatosplenomegaly.[11,12]

Prognostic Factors

Refer to the Prognosis and Prognostic Factors for Childhood NHL section of this summary for information on prognostic factors for anaplastic large cell lymphoma.

Standard Treatment Options for Anaplastic Large Cell Lymphoma

Children and adolescents with high-stage (stage III or IV) anaplastic large cell lymphoma have a disease-free survival of approximately 60% to 75%.[13-18]
It is unclear which treatment strategy is best for anaplastic large cell lymphoma. Current data do not suggest superiority of one treatment regimen over another for these standard treatment options.
Commonly used treatment regimens include the following:
  1. POG-8314/POG-8719/POG 9219: Three cycles of chemotherapy (no radiation or maintenance therapy) for stage I and stage II disease.[19]
  2. GER-GPOH-NHL-BFM-90: Prephase plus three cycles of chemotherapy (only for completely resected disease).[14]
  3. APO: Doxorubicin, prednisone, and vincristine.[15] This regimen can be administered in the outpatient setting. The duration of therapy is 52 weeks, and the cumulative dose of doxorubicin is 300 mg/m2. No alkylator therapy is given.
  4. FRE-IGR-ALCL99: Dexamethasone, cyclophosphamide, ifosfamide, etoposide, doxorubicin, intravenous (IV) methotrexate (3 g/m2 in one study arm), cytarabine, prednisolone, and vinblastine.[20] This regimen usually requires hospitalization for administration. The total duration of therapy is 5 months, and the cumulative dose of doxorubicin is 150 mg/m2.
Evidence (treatment of anaplastic large cell lymphoma):
  1. The POG-9219 study for low-stage lymphoma used three cycles of doxorubicin, cyclophosphamide, vincristine, and prednisone (CHOP).[19]
    • A 5-year event-free survival (EFS) of 88% for patients with large cell lymphoma (anaplastic large cell lymphoma and diffuse large B-cell lymphoma) was reported.
  2. The FRE-IGR-ALCL99 trial used three cycles of chemotherapy after cytoreductive prophase for patients with stage I, completely resected disease. The therapy for patients without complete resection was the same as the therapy for patients with disseminated disease.[21][Level of evidence: 2A]
    • The minority of stage I patients (6 of 36) had complete resections; no treatment failures were reported for these 6 patients.
    • The 3-year EFS (81%) and overall survival (OS) (97%) rates for patients without complete resection were not statistically different from the outcomes for patients with higher-stage disease.
  3. The German Berlin-Frankfurt-Münster (BFM) group used six cycles of intensive pulsed therapy, similar to their B-cell NHL therapy (GER-GPOH-NHL-BFM-90 [NHL-BFM-90]).[14,22,23]; [20][Level of evidence: 1iiA] Building on these results, the European Intergroup for Childhood NHL group conducted the FRE-IGR-ALCL99 study (based on the GER-GPOH-NHL-BFM-90 regimen).
    • First, this randomized study demonstrated that methotrexate 1 g/m2 infused over 24 hours plus intrathecal methotrexate and methotrexate 3 g/m2 infused over 3 hours without intrathecal methotrexate yielded similar outcomes.[22][Level of evidence: 1iiC] However, methotrexate 3 g/m2 over 3 hours had less toxicity than methotrexate 1 g/m2 over 24 hours.[22]; [20][Level of evidence: 1iiDi]
    • Second, FRE-IGR-ALCL99 randomly assigned patients to limited vinblastine or prolonged (1 year) vinblastine exposure. Patients who received the vinblastine-plus-chemotherapy regimen had a better EFS in the first year after therapy (91%) than did those who did not receive vinblastine (74%); however, after 2 years of follow-up, the EFS was 73% for both groups.[23][Level of evidence: 1iiDi] This suggests that the longer therapy in the vinblastine group delayed, but did not prevent, relapse.
  4. COG-ANHL0131 (NCT00059839) showed that the addition of vinblastine to the doxorubicin, prednisone, and vincristine (APO) regimen increased toxicity, but did not improve the survival.[9]
  5. The earlier Pediatric Oncology Group (POG) trial (POG-9317) demonstrated no benefit of adding methotrexate and high-dose cytarabine to 52 weeks of the APO regimen.[15]
  6. The Italian Association of Pediatric Hematology/Oncology group used a leukemia-like regimen for 24 months in LNH-92, with results similar to those of other regimens, although the duration of first remission was prolonged by the longer therapy.[16]
  7. The CCG-5941 study tested an approach similar to that used in LNH-92, with more intensive induction and consolidation with maintenance for 1 year total duration of therapy. Similar outcomes and similar significant increase in hematologic toxicity were observed.[17][Level of evidence: 2A]
CNS involvement in anaplastic large cell lymphoma is rare at diagnosis. In an international study of systemic childhood anaplastic large cell lymphoma, 12 of 463 patients (2.6%) had CNS involvement, 3 of whom had isolated CNS disease (primary CNS lymphoma). For the CNS-positive group who received multiagent chemotherapy, including high-dose methotrexate, cytarabine, and intrathecal treatment, the EFS was 50% (95% confidence interval [CI], 25%–75%) and OS was 74% (95% CI, 45%–91%) at a median follow-up of 4.1 years. The role of cranial radiation therapy has been difficult to assess.[24]

Treatment Options for Recurrent Anaplastic Large Cell Lymphoma

Unlike mature B-cell or lymphoblastic lymphoma, the prognosis for recurrent or refractory anaplastic large cell lymphoma is 40% to 60%.[25-27]
There is no standard approach for the treatment of recurrent/refractory anaplastic large cell lymphoma.
Treatment options for recurrent anaplastic large cell lymphoma include the following:
  1. ICE (ifosfamide, carboplatin, and etoposide).[28]
  2. Vinblastine.[29]
  3. Brentuximab.[30]; [31][Level of evidence: 2Div]
  4. Crizotinib.[32]
  5. Allogeneic or autologous stem cell transplantation (SCT).[33,34]
Although remissions can be achieved with single-agent therapy (e.g., vinblastine, brentuximab, or crizotinib), CNS progressions after therapy have been observed in patients with recurrent anaplastic large cell lymphoma. In one series, four of five patients who developed CNS progressions achieved complete remissions with either radiation therapy or high-dose methotrexate.[35]
Chemotherapy, followed by autologous SCT or allogeneic SCT if remission can be achieved, has been employed in this setting.[26,27,33,34,36]
Evidence (chemotherapy and targeted therapy):
  1. Vinblastine is active as a single agent in recurrent/refractory anaplastic large cell lymphoma.
    In one study, patients with recurrent anaplastic large cell lymphoma were treated with vinblastine alone, and the following was observed:[29][Level of evidence: 3iiiA]
    • Vinblastine induced complete remission in 25 of 30 evaluable patients (83%).
    • Nine of these 25 patients remained in complete remission, with a median follow-up of 7 years from the end of treatment.
  2. Crizotinib, a kinase inhibitor that blocks the activity of the NPM-ALK fusion protein, has been evaluated in children and adults with relapsed/refractory anaplastic large cell lymphoma.[37]
    • Of 26 patients with anaplastic large cell lymphoma who were treated with crizotinib on a pediatric phase I study with a phase II extension, 21 patients achieved complete responses.[32,38][Level of evidence: 2Div]
    • Although complete responses are common, the duration of therapy remains unclear.[39][Level of evidence: 3iiiDiii]
    • The most common adverse event was neutropenia.[38]
  3. Brentuximab vedotin has been evaluated in adults with anaplastic large cell lymphoma.
    In a phase II study of adults and adolescents with CD30-positive cancers, patients were administered a dose of 1.8 mg/kg of brentuximab vedotin every 3 weeks for approximately 1 year. The median age of patients was 52 years (range, 14–76 years). Sixteen of 58 patients (28%) had ALK-positive anaplastic large cell lymphoma, and 42 of 58 patients (72%) had ALK-negative anaplastic large cell lymphoma.
    • Complete remission rates of approximately 55% to 60% and partial remission rates of 29% were observed.[30]
    • For the 38 patients who achieved a complete remission (28 ALK-negative patients, 10 ALK-positive patients), 5-year progression-free survival (PFS) was 79%, and OS was 57%. PFS was similar for ALK-positive and ALK-negative patients.[40]
    • Sixteen patients (11 ALK-negative patients, 5 ALK-positive patients) remained in remission without the start of new therapy other than consolidative SCT at 5 or more years from the end of treatment with brentuximab vedotin. Of the five ALK-positive patients who remained in remission, four received an allogeneic SCT and one received no therapy other than brentuximab vedotin.[40]
  4. Brentuximab vedotin has been evaluated in children with recurrent or refractory anaplastic large cell lymphoma.
    In a phase II study, 17 patients (median age, 11 years) were treated with brentuximab vedotin at a dose of 1.8 mg/kg every 21 days. Twelve patients were ALK positive and five were ALK negative. After treatment with brentuximab vedotin, nine patients then received either autologous or allogeneic transplant.[31][Level of evidence: 2Div]
    • The overall response rate was 53% (9 of 17 patients), with a complete response rate of 41% (7 of 17 patients), a partial response rate of 12% (2 of 17 patients), a stable disease rate of 29% (5 of 17 patients), and a progressive disease rate of 18% (3 of 17 patients).
    • The median EFS was 4.8 months, and the OS rate at 24 months was 93.3%.
Evidence (autologous vs. allogeneic SCT):
  1. A retrospective study of relapsed or refractory anaplastic large cell lymphoma in patients who received BFM-type first-line therapy, reinduction chemotherapy, followed by autologous SCT reported the following:[27][Level of evidence: 2A]
    • A 5-year EFS rate of 59% and an OS rate of 77%. However, outcome of patients with bone marrow or CNS involvement, relapse during first-line therapy, or CD3-positive anaplastic large cell lymphoma was poor. These patients may benefit from allogeneic transplantation.
  2. Several additional studies suggest that allogeneic SCT may result in better outcome for refractory/relapsed anaplastic large cell lymphoma.[33,36,41]

Treatment Options Under Clinical Evaluation for Anaplastic Large Cell Lymphoma

Information about National Cancer Institute (NCI)–supported clinical trials can be found on the NCI website. For information about clinical trials sponsored by other organizations, refer to the ClinicalTrials.gov website.
The following are examples of national and/or institutional clinical trials that are currently being conducted:
  • COG-ANHL12P1 (NCT01979536) (A Randomized Phase II study of Brentuximab Vedotin and Crizotinib in Patients with Newly Diagnosed Anaplastic Large Cell Lymphoma): This is a feasibility study for safety and toxicity. Patients are randomly assigned to receive crizotinib or brentuximab vedotin in combination with the FRE-IGR-ALCL99 regimen of dexamethasone, cyclophosphamide, ifosfamide, etoposide, doxorubicin, IV methotrexate (3 g/m2 arm), cytarabine, prednisolone, and vinblastine.
  • APEC1621 (NCT03155620) (Pediatric MATCH: Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients with Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders): NCI-COG Pediatric Molecular Analysis for Therapeutic Choice (MATCH), referred to as Pediatric MATCH, will match targeted agents with specific molecular changes identified using a next-generation sequencing targeted assay of more than 4,000 different mutations across more than 160 genes in refractory and recurrent solid tumors. Children and adolescents aged 1 to 21 years are eligible for the trial.
    Tumor tissue from progressive or recurrent disease must be available for molecular characterization. Patients with tumors that have molecular variants addressed by treatment arms included in the trial will be offered treatment on Pediatric MATCH. Additional information can be obtained on the NCI website and ClinicalTrials.gov website.

Current Clinical Trials

Use our advanced clinical trial search to find NCI-supported cancer clinical trials that are now enrolling patients. The search can be narrowed by location of the trial, type of treatment, name of the drug, and other criteria. General information about clinical trials is also available.
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