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Small cell lung cancer (SCLC) is highly sensitive to initial chemotherapy and radiation treatment. [12] Cyclophosphamide, doxorubicin, and vincristine (CAV) is a standard first-line chemotherapy regimen along with etoposide and cisplatin (EP). Treatment options considered depend on the disease stage.

First-line treatment options for limited stage disease include [28]

Combination chemotherapy with chest irradiation (with or without prophylactic cranial irradiation [PCI] given to patients with complete responses):
- Etoposide + cisplatin + 4,500 cGy chest radiation therapy
Combination chemotherapy (with or without PCI in patients with complete responses), especially in patients with impaired pulmonary function or poor performance status.

Surgical resection followed by chemotherapy or chemotherapy plus chest radiation therapy (with or without PCI in patients with complete responses) for patients with stage I disease.

First-line treatment options for extensive stage disease: [28]

Combination chemotherapy with one of the following regimens with or without PCI given to patients with complete responses: The following regimens produce similar survival outcomes:
- CAV: cyclophosphamide + doxorubicin + vincristine
- CAE: cyclophosphamide + doxorubicin + etoposide
- EP or EC: etoposide + cisplatin or carboplatin
- ICE: ifosfamide + carboplatin + etoposide
- Cisplatin + irinotecan
Other regimens that appear to produce similar survival outcomes but have been studied less extensively or are in less common use include:
- Cyclophosphamide + doxorubicin + etoposide + vincristine
- CEV: cyclophosphamide + etoposide + vincristine
- Single-agent etoposide
- PET: cisplatin + etoposide + paclitaxel
Radiation therapy to sites of metastatic disease unlikely to be immediately palliated by chemotherapy, especially brain, epidural, and bone metastases.

Identification of effective new agents is difficult in patients who have previously been treated with standard chemotherapy because response rates to agents, even of known efficacy, are known to be lower than in previously untreated patients. This situation led to the suggestion that patients with extensive disease who are medically stable be treated with new agents under evaluation, with provisions for early change to standard combination therapy if there is no response. Such a strategy has been shown to be feasible, with survival comparable to survival with initial standard therapy, as long as the patients with extensive disease are carefully chosen. A variety of other strategies have been proposed, depending on the activity of the new agent in other tumors, in preclinical small cell lung cancer models, or the activity of drug analogs. Active single agents undergoing further evaluation include paclitaxel and Hycamtin.

While complete response rates to this initial therapy are positive, the response durations are short. [12]

Second-line treatment options

The prognosis for patients receiving second-line therapy after relapse is poor. Expected median survival is 2 to 3 months. [28] There is currently no standard second-line therapy for small cell lung cancer (SCLC), although CAV is often used after first-line treatment with EP. [12] The toxicity profile of CAV is well established and acceptable. In two studies that included sensitive and refractory patients, CAV produced second-line response rates of 13% and 28%. [12]

While no single chemotherapy regimen should be considered standard, the following have shown activity as second- line treatment:

Hycamtin
Oral etoposide
EP: etoposide + cisplatin
CAV: cyclophosphamide + doxorubicin + vincristine
Lomustine/methotrexate
Paclitaxel

For more information, please visit the following sections on this site:

Or visit the National Cancer Institute’s Web site for more treatment information.

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Important Safety Information

Indications

Hycamtin is indicated for the treatment of small cell lung cancer sensitive disease after failure of first-line chemotherapy.*

*In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing ≥60 days (in the phase III study) or ≥90 days (in the phase II studies) after chemotherapy.

Contraindications

Hycamtin is contraindicated in patients who have a history of hypersensitivity reactions to topotecan or to any of its ingredients. Hycamtin should not be used in patients who are pregnant or breast-feeding, or those with severe bone marrow depression.

Warnings

Hycamtin should be used only in patients with adequate bone marrow reserves, including baseline neutrophil counts of at least 1,500 cells/mm³ and platelet counts of at least 100,000/mm³. Frequent monitoring of blood counts should be instituted during treatment with Hycamtin.

Patients should not be treated with subsequent courses of Hycamtin until neutrophils recover to >1,000 cells/mm³, platelets recover to >100,000 cells/mm³, and hemoglobin levels recover to 9.0 g/dL (with transfusion if necessary). Severe myelotoxicity has been reported when 5-day dosing of Hycamtin is used in combination with cisplatin.

Hycamtin may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with Hycamtin.

Drug Interactions

Concomitant administration of G-CSF can prolong the duration of neutropenia, so if G-CSF is to be used, it should not be initiated until 24 hours after completion of treatment with Hycamtin.

Myelosuppression was more severe when Hycamtin, at a dose of 1.25 mg/m²/day x 5 days, was given in combination with cisplatin at a dose of 50 mg/m² in phase I studies. In one study, 1 of 3 patients had severe neutropenia for 12 days, and a second patient died with neutropenic sepsis.

Adverse Events

The most common serious adverse event is myelosuppression.

Severe neutropenia, the dose-limiting toxicity for Hycamtin, occurred in 78% of 879 ovarian and small cell lung cancer patients treated. Other hematologic adverse events reported include severe leukopenia (32%), severe thrombocytopenia (27%), and severe anemia (37%).

Frequently reported nonhematologic adverse events associated with use of Hycamtin included nausea (64%), vomiting (45%), diarrhea (32%), alopecia (49%), fatigue (29%), and dyspnea (22%). Most nonhematologic toxicities were grade 1 or 2.

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